chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had both Covid Moderna vaccines.  After each vaccine she felt lousy but after second vaccine she had rash all over body, itchiness, hives, eyes and facial swelling. It lasted for 2 weeks after vaccine.It occurs every time she works out now. She recently was out hiking and had rash all over body and itchiness.
After the 2nd covid vaccine dose on 4/15/21 she had right arm pain for 1 week, and within 1 hour colicky right upper quadrant abdominal pain started. After that time, she had bouts of colicky RUQ pain every month lasting for 2-4 days. After the 3rd covid shot on 12/13/21 the pains increased to where she consulted me on 1/31/22 for work up.  Labs revealed elevated alk phos 571 (37-153), AST 57 (10-35) and globulin 4.2 and low albumin 3.3, normal AFP 4.3 and normal PT, PTT. Abdominal ultrasound 2/17/22 revealed GB with stones and solid vascular mass in right lobe of liver (10.6x7.6x8.5 cm) with ductal dilation compatible with malignancy. MRI on 2/23/22 revealed 11x9x16 cm mass occupying most of the right hepatic lobe.
No adverse event reported yet. Notified patient to expect similar side effects to second dose. Also informed MD of 3rd dose.
This spontaneous report was received from a health care worker (medical assistant) and refers to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of Hepatitis B (manufacturer unknown) and on an unspecified date experienced an unspecified reaction to Hepatitis B vaccine (manufacturer unknown). Additional information has been requested.
mom states pt recv vax between 3-4PM 9JUL96;pt started crying immed & cont almost solidly x 8hr;mom gave APAP pt fell asleep for a few min @ a time but wouldn't lie down or stay asleep;cry was higher pitched than usual;
10:00 am 5 min 1p Hep A and HPV pt fell back on table loosing conscious-but responded immediately. B/P 110/64 HR 44-Highest HR 60 but returned to 44-45. After 10 min, B/P 98/60. Remained bradycardic-911 called for transport -pt left awake and alert w parents to ER.
Had Headache at 12pm and when I  got up at 6am I notice a rash on my neck and itchy.
Initial symptoms were pain at injection site and fatigue.  Fatigue became more significant by 5/27, with patient taking a 3hr nap in the middle of the day after having slept 12-13hrs at night.  That night she had a fever of 101.5.  Gave Ibuprofen (7.5ml).  On 5/28, took a 5hr nap after sleeping through the night.  Complains of full body pain, pain under armpits, both arms and legs.   On 5/29, screaming in pain when touched.  Does not want to walk, when she tried to walk she is wobbly, unsteady gait, off balance.  Have to carry her to use toilet.  Even gentle touch hurts her.  Complains of arms and legs hurting. Sleeping most of the day. On 5/30, extremely lethargic.  Only awakes if loudly spoken to, complains of body pains, especially legs.  Cannot walk or hold self up.  Legs seem extremely weak and balance is off.  Put her in bathtub in hopes it would help muscle aches, but she fell asleep in bathtub.  Decide to take her to Medical Center Emergency Room in.  After an extremely long wait, she gets seen by a provider.  CT scan and blood work were ordered, results were normal.  She is given IV fluids and toradol for pain.  Gait continues to be unsteady, but move improves with pain medication.  Neurology team assesses her and ultimately decides that it is not neuro related.  No clear diagnosis given.  We are discharged home.  On 5/31, Patient is still screaming in pain, less pain in arms but significant pain in legs and now stomach.  Cannot walk without holding onto us or a wall/railing.  Sleeps most of the day.  Have to carry her to bathroom.  6/1 - 6/2:  No longer walking on own, has to hold our hands and is terrified to walk.  Says it really hurts.  Keeps saying she doesn't feel good. Mentions her legs are itchy.  Continue to give ibuprofen for pain.  Sleeping most of the day.  6/3:  Took Patient for follow-up with pediatrician.  Was referred to Infectious Disease Specialist, Neurology, PT/OT and Behavioral Therapy.  BAck log at Medical Center.  Very difficult to secure appointments.  6/4:  Still hesitant to walk.  Screams, cries, yells when we try to get her up to ambulate.  Still complaining of pain in belly and legs.  Still says legs feel itchy .  6/5: Today is better.  Patient woke up in better spirits.  No pain.  Have not given Ibuprofen.  Takes initiative to try walking by herself.  Unsteady, wobbly gait, but can do it on own without holding our hand.    6/6:  Walking on own, still unsteady gait, but no pain.  By end of day, she is is very tired from practicing walking.  Appetite was slightly decreased throughout.  Lost about 5lbs, but mainly due to not wanting to feed self.  We have been feeding her while laying on the couch.   She has missed 7 days of school at this point.  Cannot send her back until gait improves.    My husband and I have also had to pivot with work to provide care for her.   Appointment with Infectious disease specialist on 6/8 and Neurology on 6/10.  Hoping to get some clarity.
my face and neck began to turn red; i felt flush; had chest tightened; I felt slightly dizzy; This is a spontaneous report from a non-contactable consumer (Patient). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 13Mar2021 at 08:30 (at the age of 63-year-old), as dose 1, single in right arm for COVID-19 immunization at hospital. Medical history included cancer of the vocal chord. Patient's past drug included Fosaprepitant and experienced drug allergy. Concomitant medications were not reported. Patient did not receive other vaccines in four weeks. On 13Mar2021 at 09:00 AM, the patient's face and neck began to turn red and the nurse first noticed it. After a few minutes, patient felt flush, chest tightened and felt slightly dizzy. Adverse events resulted in Emergency room/department or Urgent care. Patient received treatment for adverse events with intravenous Benedryl. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was resolved on unspecified dates in 2021.  No follow-up attempts are possible. No further information is expected.
having bad headaches and can't even hold her head up; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "having bad headaches and can't even hold her head up".  Additional information: The husband of patient reported that he and his wife got he booster dose of the Pfizer Covid Vaccine on 27Sep2021. The reporter said that he had some shoulder discomfort. His wife was having a bad headache. The reporter was wanting to know if these were normal side effects. The reporter stated that his own shoulder discomfort had gone away; but his wife could not even hold her head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3.9.2021, 1800 the patient was at home noticed she had a rash. 1930 she took some Benadryl.  3.10.2021, 0030 the patient was experiencing tightness in her chest, shortness of breath and dizziness upon standing.  3.10.2021, 0830 at work, she reported to me, her Nurse who had administered the vaccine, that she had a reaction the night before.  The patient stated she felt her symptoms had improved greatly and she still has a mild rash.
Mom reports non stop crying x increased 8 degrees after vaccines. TYLENOL not effective. Went to ER but was not seen as had calmed by the time they arrived.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. 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 has been requested.
Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM.  At approximately 1505 pt c/o nausea and ran outside.  Pt awake, alert, respirations easy and unlabored, no distress noted.  No vomiting occurred.  Pt stated history of throat swelling and facial swelling/rash after PCN.   1510: Pt stated nausea resolved.  Pt Diabetic and had not eaten lunch.  Juice and crackers given, pt tolerated well with no difficulty.  Respirations remain easy and unlabored, no distress.   1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences.  Pt to triage area via wheelchair by RN. BP 171/80  | Pulse 77  | Resp 17  | LMP 02/01/2013 (LMP Unknown)  | SpO2 98%    1523: Pt awake, alert, c/o difficulty breathing.  RN called for assistance   1526:  911 called. BP 184/84  | Pulse 82  | Resp 20  | LMP 02/01/2013 (LMP Unknown)  | SpO2 100%    1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now.   1530: Epinephrine given per MD order.   1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN.  During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
Body pain, temperature lasted 4 days after the injection, tinnitus in my left ear, Around where they put me the injection it felt hot and I got an allergy red spot that lasted a week or more, headache still hurts.
Patient was given a pediatric dose of pfizer vaccines instead of the bivalent pfizer vaccine that was requested.
1wk p/vax pt began having high fever & presented to ER in status epilepticus;responded to anticonvulsants;hosp 3.5 days;apparent full recovery;
RECEIVED GARDASIL #2 6/7/07.  SUBSEQUENTLY ARM BECAME MARKEDLY SWOLLEN, TENDER, AND ERYTHEMATUS.  HAD DECREASED R.O.M.  SAW DR. WHO PLACED PATIENT ON KEFLEX FOR 10 DAYS.  ON 7/2/07, ARM STILL TENDER WITH 3CM ERYTHEMATUS NODULEAR TENDER TO TOUCH.
HEADACHE; FEVER; This spontaneous case (PVX2019-1418) was received from a physician on 03-Jun-2019. It describes an 8-year-old male child consumer who had fever and headache, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 01-Jun-2019. On 02-Jun-2019, he had headache and fever (103 degree Fahrenheit to 104 degree Fahrenheit). He took oral ibuprofen (200 mg) for treatment and his physician assumed that he took 3 doses of it. He reported that he had no other symptoms and not had any similar reaction to other vaccines in the past.   The consumer did not take any other medications.  The consumer was allergic to peanut.  Action taken with Vivotif was unknown.  The consumer had not recovered from the events fever and headache.  Company's Comment: In this case, it was reported that the consumer had fever and headache after the intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, fever and headache are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had fever and headache after the intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, fever and headache are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
A 17 year old female with intermittent chest pain and a history of allergies had received her first left deltoid dose of Menactra, lot number U2154CA, on 9/12/06. That evening, the pt experienced increased temp (temp not reported), body sweats and injection site soreness. The next day, the pt continued with increased temp and was experiencing neck ache, back ache, puffy eyes, and continued body sweats. The next day, her temp was 10130 deg F for which she took Tylenol, and her eyes were still puffy. The following day, the pt was evaluated by her physician and she reported symptoms of muscle spasm, headache, and continued elevated temp (temp not reported), puffy eyes, neck ache, back ache and body sweats. The physicians office complaining of same symptoms, and the physician referred her to the ER. On arrival to the ER the pt complained of additional symptoms of photosensitivity, and she was admitted for further evaluation. A spinal tap was performed ans was positive for some type of infection, however the viral and bacterial cultures were neg. All other lab work was normal. Treatment received was not reported, and the pt was discharged on 9/19/2006, three days after admission. The pt was seen in the physicians office the day after she was discharged from the hospital on 9/19/2006, complaining of low grade fever, headache, upper and lower back pain, pain from the top of her legs to her feet, and difficulty walking due to her pain and symptoms of weakness. New lab work was ordered, but the results were pending at the time of this report. The pt was to have a neurological consult. At the time of this report, the pt had not recovered from these adverse events.
Itching started Sunday night on arms and has moved to more of the body.  The itching continues with welts.  Itching is from torso throughout upper body.  No itching on face or legs.  Itching is worse at nights.  The first night after vaccine I did run fever and headache but those symptoms were gone the next morning.
PAIN, LOWER BACK, BETWEEN THE SHOULDER BLADES, CANT MOVE ARM/SHOULDER
Extreme aching, soreness, and pain. Mainly in hips but throughout the legs as well. Lasted approximately 4 days. Sought no outside treatment at the time.
Mother stated that child has swelling on the left arm from the shoulder to the elbow. Symptoms noted on 3/27/07 in the morning. Mother added that the site was feverish. I informed mom to call her child's physician.
pt rt arm swollen from upper arm down a little past elbow red, tender, dec ROM-mild chills-no temp;rx cefzil & pred;
A patient received a dose of PROQUAD at 11 months and 10 days of age, and a second dose of PROQUAD at 12 months and 1 day of age; A patient received a dose of PROQUAD at 11 months and 10 days of age, and a second dose of PROQUAD at 12 months and 1 day of age; This spontaneous report was received from a physician referring to a 11-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 26-APR-2019 (at 11 months and 10 days of age), the patient was vaccinated with the first does of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, subcutaneously for prophylaxis (lot # and expiration date were not reported) (product administered to patient of inappropriate age).   On 17-MAY-2019 (at 12 months and 1 day of age), the patient was vaccinated with the second does of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, subcutaneously for prophylaxis (lot # and expiration date were not reported) (inappropriate schedule of product administration).
she has flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age female patient who has flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious she has flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event she has flu.
Hypothyroidism-symptoms started in September 1998, 2 months after the first dose of anthrax. Diagnosed May 2000 by labs and radioiodide thyroid uptake scan. August 2001: pt continues to experience daily cold intolerance and constipation, having a bowel movement approximately once a week. She has managed to lose approximately 10lbs by exercising, going from 143lbs. to 132 lbs. She is currently under ongoing evaluation by the gasteroenterology service. Perennial allergic rhinitis. chronic idiopathic abdominal pain. A follow up report received 6/26/2003 adds: Since her last VAERS report, pt's symptoms of fatigue have resolved. Her difficulty with concentration has improved significantly. She denies cold intolerance or constipation. She continues to have problems with unexplained weight fluctuations. She has not followed with Endocrinology regarding her hypothyroidism, but was urged to do so. Continues to get occasional "dark spots" on her skin "now and again" but has not had dermatologic evaluation. She has not received anthrax vaccine #6 at this time.
Patient presented to pharmacy on 11/12/19 stating that she had pain and soreness in the arm she received the flu shot in and said it was hard to move for the past month. She saw her primary care MD two weeks ago who told her that her brachial nerve may be involved and is referring her to a neurologist for an EMG.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-JUN-2008, the patient was vaccinated at a community clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-MAY-2014, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient has 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. Additional information has been requested.
The day following the vaccine, I experienced the usual: fatigue, body aches all over, pain in the arm and shoulder of the vaccinated arm, chills, slight fever.  I took Tylenol and rested.  Most of those symptoms were gone by the morning of the second day.   In the middle of the third day, I began to experience dizziness, lightheadedness and nausea.  I am prone to vertigo, so I began to take Zofran ODT 4mg, as needed.  I had one afternoon of full-fledged vertigo, followed by dizziness for 4 days.  I felt lightheaded for another week.  Not sure if this reaction was related to the vaccine, but I've read about other cases where this happened after the second vaccine.  I had not had an episode of vertigo for more than a year prior, and comparatively, this was milder.  Also, the arm/shoulder pain lasted for approximately 3 weeks.  Occasionally, I took a Tylenol to help me sleep, because I would awaken in the middle of the night with pain. It didn't help much. I do have severe arthritis in that shoulder.
pt recv vax 25JUL95 & MAY97 pt devel chickenpox from which subsequently recovered;
vaccinated from a vial which was first punctured 22 hours before the vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated from a vial which was first punctured 22 hours before the vaccination) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated from a vial which was first punctured 22 hours before the vaccination). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (vaccinated from a vial which was first punctured 22 hours before the vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided It was reported that the patient had not developed any side effects. No treatment medications were provided.
Vaccine given 05/05/2003 left upper arm onset erythema on same day but worsened with edema noted on day #3.  Patient seen on 05/07/2003 and given 10 doses Keflex.  Will follow up
79-year-old male with past medical history of diabetes mellitus type 2 complicated with hyperlipidemia, GERD, hypertension, osteoporosis/vitamin D deficiency, history of prostate cancer s/p prostatectomy, history of left inguinal hernia repair who presents with altered mental status, weakness, feeling sick since past 2 days. Admitted for dehydration and COVID.  There was some concern for stroke initially but CT head was never done by ED/admitting team due to inability to get it done.  Eventually done next day.  By then patient AMS had improved. Given his hyponatremia and significant AMS  ( metabolic encephalopathy due to COVID and dehydration) on arrival, observed overnight and rehydrated for another day. Received Remdesevir X 2 while in hospital.  Didn't require steroids as not hypoxic.
Arm numbness/tingling. Starts at wrist, works up full length of arm in course of  15-30 minutes. Lasted an hour straight, then subsided, had started again .
Patient was very nervous about needles & after administration of vaccine she had seizure, little shakiness & rolling of eyes. She was ok after few seconds when her mom talk to her & help her to relax.
Covid 19 positive on 28MAR2021; This is a spontaneous report. A contactable female consumer non- healthcare professional(patient) via measurable supplier other. A female patient of unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (solution for injection/Batch/lot number: unknown) via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient's relevant medical history and concomitant medications were unknown. It was reported that the patients had taken COVID-vaccine on 23Mar2021 and the patient had experienced covid 19 positive on 28Mar2021. Patient second dose was scheduled on 13Apr2021. Outcome of the event was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360085 Diffferent patient, same drug and event
w/in 1hr of vax returned to office-mom said had 3-5min episode of being apneic, non-responsive, & turning dusk;on arrival to the office had good color w/nl exam;