chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a Physician Assistant concerning an 18 year old female student with a history of tuberculosis test positive with Mantoux test and negative with chest x-ray who on 25-JAN-2007 was vaccinated IM with a first dose of Gardasil, lot # 653650/0702U. Concomitant therapy included Nuvaring. On 29-MAR-2007, at AM the patient was vaccinated with a second dose of Gardasi into the left arml. The night of 29-MAR-2007 she developed pain in the medial aspect of her left foot with swelling. On 30-APR-2007 (next day) she developed swelling of both feet. She also developed swelling along medial aspect of right foot. She tried a pain medication DICLOFENAC which was given to her for another condition without relief. She then had blisters on both hips and swelling of her lower lip. On 04-APR-2007 she was seen in the Urgent Care and was treated with Diclofenac, Claritin D and tapered Prednisone for 6 days. Sedimentation rate, complete Blood Count with differential studies performed. Lymphocytes was slightly elevated which was 48.5 HGB was 13.7. HCT was 39.9 and WBC was 6.3, Sed rate was at 16. The patient was seen on 06-Apr-2007 and 18-Apr-2007. The patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007; 7/6/2007. Additional information is not expected.
Pt. returned to clinic 8/16/13 c/o left arm mild edema (R), fever since 8/14/13 and mild reddened 2cm x 2cm on (L) arm. No drainage. KEFLEX 500g PO every 8 hr for a week. Pt. was seen on 8/19/13 for f/up and improve swollen/edema on arm. Pt. still reports fever and pain decreased, redness resolved.
Pfizer COVID Vaccine EUA: Formulation/Dosage Error Patient received Pfizer vaccine on 3/5/2022. The product provided on 3/5/2022 was 0.3 ml of the adult formulation
Pt. developed a deep vein thrombosis and subsequent pulmonary embolism after his 2nd moderna vaccination for covid 19.  He developed symptoms about 2 days after his 2nd vaccination and was diagnosed about 2 wks later with L DVT and pulm embolism  This pt. likely has a predisposition to clotting as he has a history of pulmonary embolism in 2015
Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt stayed 20 minutes and parents picked up patient and pt was okay leaving the pharmacy.
Chills; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient complained of having chills and evening fevers after receiving Shingrix.
diagnosed her with inflammatory breast cancer; experienced chills and such that started in the middle of the night; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; This is a spontaneous report a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in the left arm on 04Mar2021 (Lot number: UNKNOWN) as single dose for COVID-19 immunisation. Medical history included ovarian cancer (12 years ago and she survived). Concomitant medication included ibuprofen. The patient reported after 1st dose she was diagnosed her with inflammatory breast cancer. The patient experienced chills and such that started in the middle of the night. She had no real aches and pains in that first couple of days. The patient reported that a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling. She noticed some unusual things happening with her breast and at first she thought that she didn't know if it was from the COVID vaccine or if maybe she had hit something. But within a week or two she had severe breast swelling and noticed other bruising. After that first COVID vaccine she thought that it was an unusual thing that happened so she called her doctor and they have now diagnosed her with inflammatory breast cancer which comes up quickly and can't always be diagnosed on a mammogram. It wasn't with a lump that they decided to see if she had this, it was because of the swelling and bruising. The doctor said well it could be coincidental with the COVID vaccine but it is awfully strange that this came up shortly after the first vaccine. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
After 20 minutes the following happened... Dizzy, high,, very hot, labored breathing. I then fainted. I then had blurred vision  and need to go to bathroom. Made it to bathroom and had loose stools. I later got very. Cold. This entire episode lasted 30 minutes
Swollen lymph nodes, largest on left side collar bone; Lymph nodes painful to the touch; Visible swelling under skin; Jaw muscle cramps; Clenching; Facial soreness; Fatigue; Body wide muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, suspected hypophosphatasia, chronic migraines, peptic ulcers, IBS (irritable bowel syndrome), hiatal hernia and bone lesions. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) glucosamine hydrochloride; methylsulfonylmethane (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021, the patient experienced swollen lymph nodes which were painful to the touch, the largest on the left side collar bone with a visible swelling under the skin. On 10Apr2021, the patient also experienced jaw muscle cramps and clenching which lead to facial soreness, fatigue and he also had body wide muscle soreness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes which were painful to the touch, visible swelling under skin, jaw muscle cramps, facial soreness, fatigue and body wide muscle soreness were not resolved, at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 04-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2015 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine given below deltoid and patient's left arm is bruised from below deltoid to below elbow. Patient takes warfarin so bleeds more than usual. She reports she had pain the day of the vaccination.
pt recvd shot on 10MAR93; 7PM on 10MAR fever started; peak was 102.8; pt was irritable & lethargic; leg tender to touch;
Pt got the Hep A shot on Jan 19, 2012 in the morning. Low grade temperature (99.6) started on Jan 20, 2012 in the morning shortly after pt woke up. Fever has worsensed since then, rarely dropping below 100 degrees. Sunday, temperature spiked to 103.1 and pt was very weak and shaky and could not even stand up straight. Have been alternating ibprofen and acetaminophen since Friday as well as giving her lukewarm baths. Pt was very lethargic and tired all weekend. She woke up this morning (1/23/2012) and was running a temp of 101.3, wheezing, and small rash on arm. Called the dr and took her in. Flu swab came back negative and then Dr. said she might have a little ear infection and prescribed penicillin. Pt has not been pulling on ears at all nor has she been acting like she has an ear infection at all. She has not been sick for the last 15 months except for when she got the Prevnar shot last month and was sick for a week.
heart palpitations/periodically heart palpitations; clouded ears; ringing in the ears; swollen feet; brain fog; weight gain; its hard for me to hear at times; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2022 as dose 2, 0.3 ml single (Lot number: FK9894) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 33036BD, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2022, when the patient was 39-year-old, for Covid-19 Immunization, reaction(s): "heart palpitations"; BNT162b2 (Dose Number: 1, Batch/Lot No: 33036BD, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2022, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "clouded ears", "ringing in the ears", "swollen feet", "brain fog", "weight gain".  The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "heart palpitations/periodically heart palpitations"; INNER EAR DISORDER (non-serious), outcome "not recovered", described as "clouded ears"; TINNITUS (non-serious), outcome "not recovered", described as "ringing in the ears"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "swollen feet"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; WEIGHT INCREASED (non-serious), outcome "not recovered", described as "weight gain"; HYPOACUSIS (non-serious), outcome "not recovered", described as "its hard for me to hear at times". The events "heart palpitations/periodically heart palpitations", "clouded ears", "ringing in the ears", "swollen feet", "brain fog", "weight gain" and "its hard for me to hear at times" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, inner ear disorder, tinnitus, peripheral swelling, feeling abnormal, weight increased, hypoacusis.  Clinical information: Patient reported that, I received the first dose on 16Feb2022 and second dose on 16Mar2022 but after both doses I experienced clouded ears, ringing in the ears, heart palpitations, swollen feet, brain fog and weight gain. Still til this day in Sep2022 experiencing clouded ears where its hard for me to hear at times and periodically heart palpitations, brain fog, and increase weight gain. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not have covid prior to vaccination. Patient did not have covid tested post vaccination. There were no known Allergies. Other medical history was none. No other vaccine was taken in four weeks. No other medications were taken in two weeks.
Patient presented to ER on 1-10-07 with swelling and redness to right arm was given antibiotics. Returned back to ER with increase redness and swelling to right arm was hospitalized for two days for IV antibiotics. 03/14/07-records received from facility for ER visits on 1/10/07 and 1/12/07 DX:cellulitis post tetanus vaccine right upper arm. Temp 98.6 admitted for IV antibiotic therapy.
Pain at injection site after second dose.; Is pregnant yes; This is a spontaneous report from a contactable consumer. This consumer reported information for mother. This is a maternal report. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: not reported), via intramuscular in Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: not reported), via intramuscular in Apr2021 as dose 1, single for COVID-19 immunisation and was pregnant. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19 was unknown. On an unspecified date in Apr2021, the patient experienced pain at injection site after second dose. Patient was pregnant at the time of vaccine in Apr2021. The mother reported she became pregnant while taking bnt162b2. Delivery date reported as May2021. Seriousness criteria reported as no. The patient did not receive treatment for the events. Outcome of the events was recovered in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
5 mins after Pt received the J&J vaccine, Pt started c/o a cold feeling sensation to his forehead and weakness. On evaluation of the pt, pt appears to be lethargic, skin: cool & clammy.  AOx4, BP 135/82, HR 50, SAT 95. EMS was called to assist due to pt HR, and weakness. EMS arrived 10:35 and assumed care of pt.
Pt also c/o bodyaches, muscle pain x 3 days. Pt c/o severe body aches for several days, mostly from the waist down. He gets some relief with Advil. He also feels weak. He has had low grade fever and chills. Denies ST. Has good appetite. Mild congestion. He presented with abdominal pain. X 2 weeks, possible stomach flu. In addition, he presented with fever.
Information has been received from a physician concerning a 23 month old male with pervasive development disorder and no known allergies who on 19-Sep-2000 was vaccinated with a first dose of varicella virus vaccine live (lot #635188/0761K). There was no concurrent medication. It was unknown if there was an illness present at the time of vaccination. Subsequently, the patient has had two episodes of herpes zoster both on the left shourlder in the C5 dermatome. On 20-Aug-2001 he was diagnosed in a hospital emergency department with herpes zoster. On 12-Aug-2003 he developed herpes zoster for the second time. On 14-Aug-2003 a specimen was obtained from one of his lesions. Fifteen lesions were noted and most were drying up. The PCR results, from an adequate specimen, were negative for VZV and HSV. The physician reported that the patient is a normal healthy child on no medications; however he is in foster care and was a high risk at birth for congenital HIV. The physician heard via "third-hand" information that the patient's HIV screening at birth was negative, however she has not been able to confirm this. The physician is planning on obtaining consent from the foster parents for HIV testing for the child. Follow-up information from the physician indicated that 12-Aug-2003, approximately 20 roughly similar vesiscles were noted. There was no recent exposure to chickenpox or shingles. on 14-Aug-2003 the physician reported that the child was happy and playful. Some lesions were dry and no acyclovir was given yet. His birth history was unknown "crack exposed" and his NBS was "WAL". His physican examination was otherwise notable for a large head and obvious delay. He was also diagnosed with PDD (date unspecified) by neurology and psychologists. On 11-Sep-2003 the physician reported that the chidl was recovering at the time the specimen was obtained and now has completely recovered. She reported that "he is otherwise healthy and does not look like and HIV infected child". No further information is available.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS instructions.
Developed skin irritation and lymphadenopathy on left side of neck on evening of 1/14/21. Friday 15th noted posterior left sided neck rash. Saturday 16th noted more pronounced lymphadenopathy and progression of irritating rash.  Monday 18th made appointment with infectious disease, diagnosed with shingles (VZV), started on antivirals for treatment
irritable, screaming 1 day p/vax-for 2 to 3 wk;
Patient is a resident of a SNF - found to be COVID 19 + 6 days prior to admission on 7/19. Pt reported to have minimal symptoms - on O2, but unknown if this is baseline. Patient admitted with GI Bleed; underwent colonoscopy and removal of a oozing polyp. Patient tolerated procedure well, but continued to decline in terms of mentation during hospitalization including the use of sedative medications and restraints. On 7/25 patient and family decided to proceed with comfort/palliative care. Patient passed on 7/26. Although patient was COVID positive, there is no indication that his death was directly due to COVID.
No adverse effect; Patient received dose of GARDASIL 9 in August 2018 and 2nd dose of GARDASIL 9 on 15-MAY-2019; Patient received dose of GARDASIL 9 in August 2018 and 2nd dose of GARDASIL 9 on 15-MAY-2019; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, current conditions and concomitant medications were not reported.  On an unknown date in August 2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis.  It was reported that on 15-MAY-2019 the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration and circumstance or information capable of leading to medication error).  The patient experienced no adverse event.  No PQC (product quality complaint) was present.
Occasional slurring speech and loss of motor control when walking (stumbling) Incidents have occurred about a dozen times. Most recently someone other than me noticed the slurring of speech that I've been ignoring.
Within 4 hours of receiving second dose of MOderna Covid 19 vaccine, patient began experiencing tinnitus b/l. Since then  , now 6 days later, symptoms have not changed, slightly worse in right ear. On exam, some long-standing sclerosis b/l, otherwise PE was neg.
Patient is 17 years old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17 years old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021, contains no new information.
I noticed mild pain in my L shoulder in PM on 3/24/2021 but didn't think much of it as I had exercised earlier in the day. In PM on 3/25/2021 I noticed same shoulder was warm and red, and a welt had developed at the vaccine site with smaller bumps around it. It is very mildly tender. No fever noted, taken at time of discovery (98.1F); no other signs/symtoms noted
I have bumps and scabs on my whole entire back; Shortly after receiving the third vaccine, my back started to itch; I have bumps and scabs on my whole entire back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (I have bumps and scabs on my whole entire back), PRURITUS (Shortly after receiving the third vaccine, my back started to itch) and SCAB (I have bumps and scabs on my whole entire back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PAPULAR (I have bumps and scabs on my whole entire back), PRURITUS (Shortly after receiving the third vaccine, my back started to itch) and SCAB (I have bumps and scabs on my whole entire back). At the time of the report, RASH PAPULAR (I have bumps and scabs on my whole entire back) and SCAB (I have bumps and scabs on my whole entire back) outcome was unknown and PRURITUS (Shortly after receiving the third vaccine, my back started to itch) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
It started around 8:30 p.m. 4/15/21.  Right arm extremely tender and could not raise above head. Overall body stiffness and body aches. Could not move from seated to standing position that well.   Woke up the next day with a severe headache and back ache especially on the right side.  I had a fever of 102 that day.  Chills, light headed, and fatigued.  Finally subsided on Monday 4/19/21
Pain in her arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced PAIN IN EXTREMITY (Pain in her arm). At the time of the report, PAIN IN EXTREMITY (Pain in her arm) had not resolved.            It was reported as unknown if patient was under any concomitant or regular medication, or under any treatment for her symptom. No concomitant medication was not reported. No treatment medication was not provided.
pt had high pitched crying would cry x 1 1/2hr become exhausted sleep x 20 min then began w/high pitched cry again-this cycle lasted until 730-800PM that noc;