chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anticipated sore arm,; Flare up then a remission of psoriasis.; This is a spontaneous report received from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included rosacea, psoriasis, allergies, gluten intolerance and COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) and multivitamin (MANUFACTURER UNKNOWN) for unknown indications and from an unknown date. The patient previously received penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 10Mar2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 07:00, the patient experienced sore arm which was anticipated and beside that had a flare up then a remission of psoriasis. The patient never had experienced anything like that so fast and then so clear. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm and psoriasis was resolved with a sequela on an unknown date.  No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE RESPIRATORY FAILURE HYPOXIA 8/6/2022 --  RECURRENCE OF SAME SYMPTOMS
reported fever of 102.5, shivering ,loose bowels, body aches, itchy rash.  all have resolved except for rash under injection site
blood work showed she was anemic; This case was reported by a consumer via call center representative and described the occurrence of anemia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th May 2022, 2 days after receiving Shingrix, the patient experienced anemia. On an unknown date, the outcome of the anemia was unknown.   It was unknown if the reporter considered the anemia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The case was reported by the patient's husband. The patient received Shingrix vaccine in left arm and then had blood work 2 days later. The reporter stated that her blood work showed she was anemic. The reporter did not have any more information about the vaccine. The reporter consented to follow-up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091788:Same reporter
I feel pain increasing with time. It is close to the shoulder joint. My left shoulder is limited in motion. I just take pain relieve (ibuprofen).  Because I do not have insurance, still I have not gone to Doctor. It looks like to be an emergency. So, I can get Emergency Medical Assistance. In the same shoulder, I got flu vaccine at the same time. So it is 2 vaccines very close in the very upper arm.   It is one of the worst times, a nurse gave me a vaccine.
L axillary LA - starting day 9 after injection, continuing through present (Day 17)
Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Initial report was received on 01 October 2010 from a health care professional. A 65 year-old male patient with an allergy to "Td", had received an injection of FLUZONE HIGH-DOSE, lot number U3617AA (date, route and site of administration not reported) and unspecified amount of time later, experienced a "feeling" like something was stuck in his throat, puffy eyes with no drainage and he was "clearing his throat". The patient was treated with prednisone. No further information was available at the time of the report. The patient's outcome was reported as recovering. Documents held by sender: none.
Pfizer BioNTech COVID-19 Vaccine EUA  Patient given vaccine and nurse used CDC screening check list. Patient's noted yes to allergies made nurse talk to lead nurse regarding allergies. Plan of care was to vaccinate but have patient stay at least 20 minutes. During the 20 minute wait, the observer was notified by patient she was having some throat tickling and tightening. Observer notified lead nurse. Lead nurse approached patient and had her move from waiting area back into her nurses room. Patient complained of throat tickling and tightening but stated she was fine. Nurses noted increasing coughing. Pulse ox and respirations checked. Patient continued to state she was fine and was not in physical distress. Nursing director was called and nurses advised to give epi and follow protocol. Epi given in left thigh. Patient vitals monitored and patient was able to tell throat started to loosen and coughing stopped. 911 called but patient refused transport after EMS assessed patient. Nursing Director discussed patient incident with Medical Director and nurses were advised to administer a IM dose of benadryl. Patient agreed and verbalized understanding her risks of not going to ER for monitoring. Patient signed refusal for treatment form and planned to call her doctor when she left. Patient vitals were stable and patient left clinic on her own accord around 11:00 am.
On 5/12/2021 patient was complaining of generalized body aches, later in the morning when going to a pain management clinic, patient subsequently became nauseous and vomited several times during the course of the day. Reportedly had episode of dark emesis as well. Patient was then found by family around 10pm unresponsive, pale, w/ difficulty breathing, EMS was called, patient was found to be in cardiac arrest in asystole. Patient possibly had v-fib during transport and was defibrillated twice before becoming asystolic again. Patient was subsequently pronounced dead in the Emergency Department on 5/12/21 at 11:04pm.
02/12 developed fever, redness, swelling at injection site. Right thigh, which persisted through 02/14/2005
Mild arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:45 (Lot number: Er8737) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Sometimes; "Wolff-Parkinson-White syndrome" (unspecified if ongoing); "Supraventricular tachycardia" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL taken for seasonal allergy. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Mild arm pain".  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Three hours after the administration of the Pfizer-BioNTech vaccine, I started to experience heart flutters/palpitations. I also experienced a burning in the center of my chest.  The next day the burning went away, but the still to this current day (07/30/2021) I am still experiencing palpitations.
Pt was inconsolable and excessively crying for approximately 3 hours. Pt came into office, ibuprofen was administered and pt left the office in stable condition.
Swelling of the deltoid and bruising. Itching, spreading redness, tender to the touch.
pt recv vax 1MAR96 & exp inj site rxn characterized by redness & swelling, upper resp sx & devel a fever;all sx beginning to resolve as of the date of this report;
Chills, high fever started 6 hours after the injection. Had to take 650 mg Tylenol every 4 hours to keep the fever a bit low (the fever would not go below 101.5). After 20 hours, could control the fever with every 6 hours of Tylenol (650 mg). Took medication for 40 hours. The fever went down but had chills for 3 days. less than 72 hours after the injection had a miscarriage. Was 5 weeks pregnant at the time of miscarriage.
Vasovagal episode following vaccination. Spontaneous resolution after being put in the supine position. Paramedics on site. No treatment required.
No further information is available; The patient received PROQUAD on 6/23/2021 and VARlVAX on 8/26/2021; The patient received PROQUAD when the patient was 13 years old; This spontaneous report was received from a registered nurse, referring to a 13 years old patient. The patient's medical history and concurrent condition were not provided. Concomitant vaccine included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).     On 23-JUN-2021, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis after the recommended age (product administered to patient of inappropriate age).   On 26-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T021822, expiration date 25-JUN-2022; strength, dose, frequency and route were unknown) for prophylaxis (inappropriate schedule of product administration). No further information was available.
Had a pounding headache and dizziness when she stood up. Fever (temp not taken), freezing cold, throat felt like it was on fire. Call pt 5/9/06, mom states problems lasted approx. 2-2 1/2 days. Fully recovered.
Pt vaccinated on 29JAN91 2 hrs later became lethargic & had repeated episodes of vomiting lasting for 5hrs. Seen in office at 3PM given 02 by mask.
Pain at injection site (continued), pallor (continued), excessive diaphoresis (20 hours), nausea (continued), vomiting (12 hours), diarrhea (12 bours), extreme malaise (lessened after 20 hours but still lingers), gastric pain (20 hours), headache (continued), impaired vision (12 hours), severely weakened gait (18 hours), inability to drive (18 hours), body aches (continued), memory loss and confusion (12 hours), dyspnea (12 hours), fever of 104° F (12 hours with no relief from antipyretics/acetaminophen), fever in excess of 100° F (another 10 hours), fever in excess of 99° F (12 hours), fear of death (36 hours)
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324604, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324596 (same reporter). This case involves a male patient of unknown age who received vaccines FLUZONE QUADRIVALENT and FLUZONE HIGH DOSE after vaccines were exposed to the temperature excursion. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was also reported that eight patients were administered a dose from the box that was exposed to the temperature excursion. It was unknown if patient experienced adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm sore for 20 hours, started feeling very tired, shaking and shivering and chills. Extreme fatigue. Slept for 3 hours, then slept thru the night.  Was OK to go to work in two days.
I was very sore the next day after having the vaccine. The soreness lasted for about 3 days. I was not able to do anything but lay in bed. Chest pain started around October 17, 2022. On October 29, 2022, I went to the emergency room. My blood pressure reading was 190/110. The highest reading at home was 260/150. They treated me for an anxiety attack and gave me blood pressure medication called hydroxide HCL and sent me home. The medication caused my blood pressure to drop to 90/60 so I discontinued using the medication. Just going through my house causes me to not be able to catch my breath. I returned to the hospital around November 01, 2022. They decided to admit me. I was overmedicated again, and I passed out while waiting to be admitted. I went to the bathroom and vomited and afterwards passed out. Very late on Wednesday night I was tested for COVID-19 and was positive. I was prescribed PAXLOVID; chlorthalidone 25mg, and pantoprazole. I followed up with my cardiac doctor after I had gone through the PAXLOVID. I went to my primary doctor on the November 14th, and he referred me to a cardiologist. I was prescribed metoprolol. I went to my Ob-Gyn on November 28, 2022, and told her about having COVID and cardiac symptoms so she changed my birth control from JUNEL to SLYND. I have not had a menstrual cycle since having the COVID-19. I have taken myself off all cardiac medications as my blood pressure has returned to normal. I am in Cardiac rehab and still occasionally have chest flutters but not as intense as before.
One day after immunizations child developed irritability - swelling at injection shot. Fever up to 102 degrees.
Burning, watery eyes; headache; cough; Dizziness; Shortness of Breath; Wheezing; All occurred until 4:00am 10/19/2011 except burning eyes, which lasted until 1:00 PM 10/19/2011.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 01-APR-2013 the patient was vaccinated subsequently with a 0.65 ml dose of ZOSTAVAX (lot # H021292, expired date: 28-FEB-2014). Concomitant therapies included MEDROL dose pack, betamethasone cream and VALTREX. On 08-APR-2013, the patient developed rash about a week after receiving vaccine ZOSTAVAX. Patient developed rash on her abdomen on one side of her body, neck, head and wrist and rashes are red and itchy. Patient went to a minute clinic when rash first appeared and she was prescribed VALTREX because nurse who saw patient thought that it was shingles. However, patient subsequently followed up with her family physician and dermatologist as well and it was determined that rashes were not shingles rash but rather some sort of allergic reaction to ZOSTAVAX. The patient did office visit for medical attention. The event was treated with betamethasone cream and VALTREX. At the time of the report, the patient was not recovered from the event. Pharmacist stated that patient got HIVES from AVELOX and erythromycin gel. Additional information has been requested.
This spontaneous report as received from a health professional and refers to a patient of unknown age and gender. Information on patient's concurrent conditions, medical history and drug reactions was not reported. On 14-AUG-2015, the patient received the first  dose of GARDASIL 9 , injection (concentration, dose, anatomical location, not repreoted) which has a lot # reported as K006117 with expiration date on 14-JAN-20176. On 16-OCT-2015, the patient received the second dose of GARDASIL 9 and on 22-DEC-2016, the patient received the third dose respectively (inappropriate schedule of drug administration). At the reporting time, no adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
GIVEN SMALLPOX IMMUNIZ ON 2 SEPT 2003, ON 10 SEPT 2003 NOTICED INCREASED REDNESS AND ITCHING. MBR WAS MONITORED OVERNIGHT, HE HAD INCREASED REDNESS EXTENDING OUTSIDE OF THE AREA OF INDURATION WITH LYMPHANGITIS. PLACED ON ABX FOR SECONDARY INFECTION.
Increasing soreness at injection site that began spreading the next morning.  Redness, heat, and itching that began at the injection site and by 5/9 covered my whole upper arm.  The Redness and pain did begin to reduce on 5/10 without any medical intervention.  Contacted Dr. Was instructed to follow up if the reduction did not continue.
Very very intense  itching underside of forearm for at least 2 -3 weeks started about 15 days after injection. Used hydrocortisone cream - worked less than 30 minutes each time applied. No pain or redness around vaccine site
Vision was off for about an hour. Felt like my eyes weren?t focusing properly, but did not impact my overall vision.
Patient reports immediate onset of pain with injection. She then continued to have right shoulder pain since then. She reports pain with use of the arm and difficulty sleeping due to moving the arm. She is doing all usual activities. Physical examination today 11/4/19 indicates no erythema, no warmth, no lesions, no edema. Mild diffusely tender. Full range of motion but with pain at the end of movements in abduction and forward flexion.
pt recv vax & 2 days following vax pt devel a macular-papular rash & a fever over 102 & presented to MD:lab eval revealed neg throat cult, CXR & sinus series, along w/nl CBC;
Patient reported local reaction to the injection site such as bump, redness in circle, pain, burning. she got reaction on 2nd day post vaccination. patient reported that redness is still present on the injection site as of 1/8/21. patient is concerned for getting the second shot.
pt recvd vax 7JUL94 that evening t102 ax & sleepy thru Friday & Saturday & on Sunday 10JUL94 temp became more persistant; 11JUL94 vomited along w/rash starting; pt taken to ER: lt leg swollen;
Patient felt lightheaded within 15 minutes of dose 2. Had a similar reaction to dose 1. Vital signs remained in normal parameters and she was discharged after 30 minutes observation.
At 2:45 child received 4 vaccines: Pediarix and Hib in right thigh, influenza and PCV7 in left thigh.  At 3:00 mom returned to clinic with child in arms and reported appearance of rash.  Upon inspection, irregular and reddenned areas were noted on face, left ear, and back of neck.  3 visible hives present at approximately 5x2, 4x2, and 4x2 mL in size.  Left thigh appeared red around both injection sites, but no swelling noted.  No signs or symptoms of distress.  Respirations within normal limits.  Happy and content in mother's arms.  At 3:05, RN drew up 1.25 mL of children's benadryl per protocol and mother administered.  At 3:15 redness had diminished and hives were no longer well defined.  Staff consulted for doctor's appointment which was scheduled immediately with Dr. at Clinic.  Mother sent to Dr. with shot record, report of incident, and a map to the clinic.  Child left in mother's arms, smiling and content.
Within 6 hours of receiving the vaccine, patient experienced pain, redness, warmth at injection site. Left arm was painful and tingled and then spread to her left neck, face and head. Back pain on left side followed. Face felt 'droopy' and speech was slurred. Eyes red. She was nauseous and semi-conscious. She was seen in the emergency room.
Patient reported pain at the sight of injection a few hours after immunization was given. She reported extreme fatigue the day after immunization. She went to the doctor on July 22, 2018 and reported swelling of the arm and unable to move her left arm.
This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling) and ARTHRALGIA (Knee pain) in a female patient of an unknown age 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 JOINT SWELLING (Knee swelling) and ARTHRALGIA (Knee pain). At the time of the report, JOINT SWELLING (Knee swelling) and ARTHRALGIA (Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.   The reporter noted that the patient did not have any chronic medical problems.
Patient presents to medical center with complaints of dyspnea.  On 1/17/2022 patient started having a nonproductive cough and fever and ongoing UTI, which she was prescribed antibiotics by PCP.  During ED presentation she reports sweats, headache, body aches, dyspnea at rest and with activity and nonproductive cough, nausea, and vomiting.  Patient received Zithromax 500 mg IV, cefepime 2 g IV, and Decadron 6mg IV.  Admitted to COVID unit with acute respiratory failure.  Started on dexamethasone, remdesivir, and oxygen.  Pulmonary started patient on baricitnib.  Patient did not respond to treatment favorably.  Patient family decided to proceed with comfort care measures.  Patient expired on 1/26/22
This spontaneous report was received from a physician regarding a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with VAQTA (reported as Hep A) lot# M015290 with expiration date 20-SEP-2017 (dose, route and frequency were not reported) and PEDVAXHIB (reported as Hib) lot# L051124 with expiration date 14-OCT-2018 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726.
I developed moderately severe flu-like symptoms: fever, chills, sweating, extreme thirst, headache, fatigue, and a sore arm. I would say this is in the top 5 flus I've ever had in my lifetime. The night after the vaccination, I woke up having sweat through my shirt. At almost 3 days out from the vaccine, I'm still having episodes of feeling hot/cold/sweaty. It's as if my body can't properly thermoregulate: I get cold so I put on more layers, then I immediately get hot and start sweating. I almost feel both hot and cold at the same time. Overall, the reaction I had to the booster was markedly more severe than the reaction I had after the initial 2-dose vaccine series.