chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Monday 6/25 at 2:44 she got her 2nd SHINGRIX shot. It was in her left upper arm. Immediately after the shot the arm was sore. Around 6 PM that night she developed full body muscle aches. She vomited multiple times that night. The next day Tuesday she continued to have extreme generalized pain, and soreness in the left arm. She did not have an appetite, could not drink. She developed a fever and chills. Wednesday she continued to feel sick with fever and chills and body aches. Thursday she felt a little better, but still had excruciating left arm pain and decrease ROM of the left arm. Today Friday she comes in to be evaluated. She has bruising at the site of injection. A few inches below the injection site she has an area of redness and warmth on her arm. Her arm is still painful and cannot fully extend it.
Fatigue to the point where I could not get get out of bed.   Right hip joint painful and stiff continuously since day 2
My arm  became sore, and I was a little nauseated about 4 hours later which I expected. At 10pm I started feeling light headed and walked to the kitchen to get water. I began feeling weak and more dizzy and went back to my bedroom to lie down. I felt a rush to my head, passed out and woke up on the ground. I am unsure how long I lost consciousness:  minutes/ seconds.  I was able to get to my bed and called my husband for help. I broke into a hot, drenching sweat to the point I had to change my clothes.  The dizziness eventually cleared. I have a headache and am still nauseated today but not dizzy.  I have never had an experience like this before.
Face burning/ arm burning; Had to lay down; Sensitive to light; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Face burning/ arm burning), MOVEMENT DISORDER (Had to lay down) and PHOTOPHOBIA (Sensitive to light) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced BURNING SENSATION (Face burning/ arm burning), MOVEMENT DISORDER (Had to lay down) and PHOTOPHOBIA (Sensitive to light). On 10-Feb-2021, BURNING SENSATION (Face burning/ arm burning), MOVEMENT DISORDER (Had to lay down) and PHOTOPHOBIA (Sensitive to light) had resolved.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient said the events were resolved and also been free of events since three weeks.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No new information received.
Patient described her symptoms as "layered". About 5-6 hours after vaccine symptoms began. Tight, hot pain developed in neck. Patient took Tylenol. In the morning of 04/21/2021 pain had moved to shoulder and by 04/22/2021 morning the pain had reached her lower back. 1pm on  04/22/2021 patient developed severe urination. Patient was urinating 2-3 times an hour for the next two days. 04/23/2021, Patient's Dr. thought it was kidney stones. Patient went to Hospital 04/23/2021 where they did a CAT scan and bloodwork. Patient was prescribed tramadol, lidocaine patches and physical therapy. Other symptoms included headache, palpitations, varying blood pressure, arm soreness, fatigue and blood in urine.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot# M039202 with expiration date on 11-MAR-2018; lot# M032492 with expiration date on 02-MAR-2018; lot# M036458 with expiration date on 02-MAR-2018; lot number reported as M036153 with expiration date on 02-MAR-2018; and lot # M012261with expiration date on 01-FEB-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
STARTED WITH FEVER/BODY ACHES. LED INTO MOODINESS, DEPRESION, HISTERICAL IN A GOOD WAY IE: LAUGHING, FOGGINESS, MIND WANDERING, SNEEZING.
Patient was administered her Hep A vaccine at about 1:30pm and was sitting on the exam bed talking normally at about 1:33pm she proceeded to rock forward and jerk to the left causing her to fall of the bed onto her head and landed on her back.  Her neck, arms and legs were convulsing.  She did not respond to her name for about 10 seconds.  She opened her eyes and her pupils were dilated.  She was able to answer the questions the nurses asked of her.  She was examined for any neck injury and was moved back to the exam bed to sit and was given a cup of water.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated subcutaneously with lot # (671004/0729AA: exp date 17-AUG-2012), 0.65 ml dose of ZOSTAVAX on 24-AUG-2012. The patient experienced the patient was not experiencing any known symptoms. Additional information has been requested.
Client was vaccinated with Pfizer vaccines in April 2021.  Tested positive asymptomatic after family member became ill.  Did not develop symptoms during 10 day isolation period.
Pt reports that that following the Zostavax vaccine he had a hypoglycemic episode.  Was very shaky, vomited x1 and BGL was 60.  No sx now
On the 9th, my father suddenly froze while standing up by thekitchen sink and stopped talking. He looked as if he was losing consciousness and couldn't talk and wouldn't drink. He suddenly collapsed into my arms after i ran to get a chair so he wouldn't fall on the floor. He could barely Sir in the chair himself. He got up and tried to walk but collapsed into the chair that i had dragged over to his new spot. He say and suddenly began to faint and seemed to be dying. I called 911 and the paramedics arrived and took his vitals and said he was fine now. By the time they'd arrived, he was up and alert and able to walk and talk.  This was extremely scary as i truly though my father was dying.    He had the first dose in May and also had a reaction.  His lips blew up to a very large size. I didn't agree that he should have taken the 1st nor 2nd dose.
Injection site is still swollen and very sore day 3 post shot given. Full body muscle soreness and headache has kept me 80% bedridden. I have no temperature but the grapefruit size red knot on my arm is warm to touch. I have taken BENADRYL, MUCINEX, ALLEGRA and ibuprofen. Still experiencing side effects to date.
Fever 100 degrees. Shivering. Body aches all over. Lasted 1-1/2 days (from Saturday evening until Monday morning).
Patient felt light headed about 5 minutes after vaccination.  We had her lie down and put ice packs on her neck and forehead.  She laid down for about 20 minutes, then sat in a chair for about 15 minutes under observation.  Blood pressure and pulse was checked at 10 minutes, 15 minutes, and 20 minutes following vaccination, BP values were 107/63, 109/66, and 110/69, respectively.  Pulse values were 83, 74, and 75 respectively.  I checked on patient 3.5 hours after vaccine and she reported to continuing effects.
Patient reported skin lesions on leg on 2/27/07-pink/red and scaly papules covering area of 3 cm x 3 cm of right lower leg and small papule on right lateral knee. No fever, no chills-no systemic signs and symptoms; On 3/5/07 evaluated by doctor-vesicular rash on right lower leg with drainage, right lateral knee lesion with drainage; Pt evaluated by doctor (3/6/07) and doctor (10) on 3/7/07. Vaccinia culture sent-(hives); supportive cane and off work for 7 days; dings to all lesions. Last flu date 3/20/07 lesion-no further vesicles. doctor contacted by doctor.
Both shots, extreme body aches, terrible headache, so cold it felt like ice running through my bones, then hot. First shot temp got to 101.4 and second shot it got to 102.4 Throwing up and nauseous and dizzy.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: EMS was contacted and dispatched to the site. Patient vital signs were checked. Patient refused to be taken to the hospital. Patient felt better and was brought home by family member
patient was administered with an expired dose of the ActHib single-dose vial into the left deltoid , no reported adverse event; Initial information received on 30-Jun-2021 regarding an unsolicited valid  non-serious case from a other health professional via Information (reference number: 00663528).  This case involves an unknown age male patient who was vaccinated with an expired 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (1x single-dose vial in total, lot number UJ524AAA and expiration date 14-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Jun-2021 (expired product administered).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient had medical history of bone marrow transplant and reported that he had 5 other vaccines along with the Act-HIB (names of the vaccine available) on 28-Jun-2021.    It was a case of an actual medication error due to expired vaccine used (same day latency).  At time of reporting, it was unknown whether the patient had any adverse event.  It was reported that upon transfer, caller asked if there were any "cushion" after the expiration date of ActHib, where the product would still be good. Caller asked how to proceed if patient received an expired ActHib dose, and any safety concerns with having given an expired ActHib in a patient with his history. At the time of reporting, the outcome was unknown for the reported event patient.  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 the 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.
During pre-employment screening, associate received the Varicella vaccine and subsequently developed a reaction to the site that has gotten worse. Including a painful, itchy, red lump that is warm to the touch, along with a headache.
p/vax abruptly dropped to floor; did not respond approx 20 seconds;arms shaking sl;nose bleeding for approx 10-15min; assessed by MD, BP 92/64/T97.5;pressure applied to nose bleed;ask to drink sprite by MD; pt apprehensive when shots given
Patient is 23-year-old male with complaints of a rash noticed since this morning.  The rash began yesterday that he thought was just an occasional rash but upon awakening this morning, he noticed that they had spread.  No fevers or chills.  No nausea or vomiting.  He has been feeling okay despite being vaccinated for smallpox.  He is currently day 10 after the vaccination.  He reports the wound is starting to heal.    O:  GEN:  WDWN male NAD  alert and oriented X 3  HEENT: pharynx clear, conjunctiva clear,  neck supple without adenopathy.  LUNGS: clear with good air movement.  CV: RSR without murmurs or gallops.   SKIN:  scattered salmon colored papules at lower arms bilaterally and on the back of his neck.   MEDICATIONS: 1. None  PMH: 1. None  MED ALLERGIES: 1. NKDA  Social History: Non-smoker ETOH  occasional  Family History: No family history of problems with vaccines  Vaccine History:  No history of problems with vaccines  A/ generalized vaccinia - folliculitis (erythema multiforme)
high fever for 3-4 days then rash for 5 days;then high fever for 2 days;blotchy rash-hands peeled;pt stopped talking p/vax;lost eye contact;devel autistic traits;tx mom called ER given Ibuprofen;
had a stomach flu or virus that has past around the whole family; diarrhea; fever; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (had a stomach flu or virus that has past around the whole family), DIARRHOEA (diarrhea) and PYREXIA (fever) in a 74-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (had a stomach flu or virus that has past around the whole family), DIARRHOEA (diarrhea) and PYREXIA (fever). At the time of the report, GASTROENTERITIS VIRAL (had a stomach flu or virus that has past around the whole family), DIARRHOEA (diarrhea) and PYREXIA (fever) outcome was unknown. Not Provided          Concomitant medications were not provided.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Less than two weeks later, I have GCA, where the immune system attacks the vascular system.  I have lost vision and have double vision and extreme crushing headaches and fever, night sweats, swollen hands.
He got flu shot on 8/27/16. According to family members he was admitted in hospital on 8/28/16 and passed away on 9/8/16.
Information has been received from an infection control technician concerning a female hospital employee who in March 2005, 2 months ago, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in March 2005, the patient developed an injection site rash. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was moved from freezer to refrigerator on date of administration.  No concomitant medications were reported.  No treatment information was reported.
Given TD on 2/17; 2/19 felt weak, right side of body>left; 2/20 felt weak and foggy, noted increase left pupil size, with decreased ability to focus; 2/21 noted tingling on face with ongoing increase size of left pupil, seen emergently in my office, and then ER with neurology evaluation, no notable weakness on exam, and pupils reactive, L 2mm> R; 2/25 had MRI with MRA, neg, and neuro-opthalmology at Hospital  eval neg; seen in my office 2/26 with pupil improving, and feeling better, less weak, no motor deficits or decreased DTR's, tried on Medrol dose Pak; seen subsequently by oncology with normal lab and Xray, with last follow-up with me 3/12: L pupil still 2mm larger than R, but normally ractive, still slight tingling on face and R forearm, otherwise normal, and energy level almost back to normal/ no other cause than possible TD reaction?
HYPERTENSION; little headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (HYPERTENSION) and HEADACHE (little headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tremor. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Tremor.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (HYPERTENSION) and HEADACHE (little headaches). The patient was treated with PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Hypertension, at a dose of 30 mg twice a day. At the time of the report, HYPERTENSION (HYPERTENSION) outcome was unknown and HEADACHE (little headaches) had resolved.            Patient wanted to know if her blood pressure would come to normal as her HCP was not figuring it out.   This case was linked to US-MODERNATX, INC.-MOD-2021-072802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072802:Crossed linked
When I was eating chips I wanted to lick my fingers and my mouth felt funny. I looked in the mirror and my face looked fine. The following day I noticed half of my face was paralyzed and I went to urgent care. The Dr. diagnosed me with Bells Palsy and put me on antibiotics for 10days. I asked for more because it wasn't healing, but hey didn't me anymore. Maybe a week after I did a phone visit and asked If I should get more medicine and they said no. Maybe a week ago from today 1/27/21 I seen my PCP and she contacted the Neurology department at medical center regarding  my situation. After about 3 weeks of having this im about 90% better.
Lack of drug effect; Lack of drug effect; Diarrhea; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. Other Case identifier: 21K-163-4179780-00 (Abbvie).  Solicited report by a consumer of an elderly female with events of non-serious lack of effect and diarrhea with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced lack of effect and diarrhea. Pfizer Biontech Covid-19 vaccine (PFIZER) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 27Jan2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/Biontech. On 17Feb2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer/Biontech. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event(s) of lack of effect with humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of diarrhea was not provided.  The reporter assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the reported events and the suspect drug "BNT162B2" cannot be completely excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Stomach upset, nausea, loss of appetitie (unable to eat for 1 day), fever (temp not known by mother), sweating at night/early morning, dizziness. Neck pain - woke patient in early morning hours. S/s reported to occur for past 2 days. Patient experienced dizziness and faint-like episode (No syncope) day of vaccine.
A territory representative reported that the patient developed a large amount of swelling at the injection site. The patient was treated with antibiotic. The reporter indicated that 2 patients experienced this event; however, they are not presently identifiable.
Yearly check up. Dr suggested the PREVNAR 13 vaccine. Four days later fever onset, bronchial tubes closing. Two more visits, 2 courses of antibiotics, and bronchitis tests. I am a non smoker and never had bronchitis in my life. Now I'm diagnosed with it.
Information has been received concerning a female who on 07-APR-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Upon investigation of an allergic reaction, it was determined that the customer was given an influenza virus vaccine (unspecified, manufacturer unknown) by a pharmacist. The influenza vaccine was administered correctly and according to protocol. The customer stated that she had an allergic reaction to the vaccine (not specified to which vaccine the reaction occurred). She did seek medical treatment (unspecified). The outcome of the allergic reaction was not provided. Information was received from a telephone call. On 03-MAY-2012, it was verified that the patient was vaccinated with ZOSTAVAX (Merck), not the flu vaccine. Additional information is not expected.
high blood pressure-medication for life. vision blind-laser treatment cramps legs. joint aches/urinary frequency/weight gain abdomen cramps/pain lower back/sinusitis/
Initial report received on 10/3/06 from a health care professional. A 50 year old female pt, with an allergy to Vicodin and Penicillin, had received a left deltoid dose of Fluzone SV 2006-2007 USP, lot number U2192AA, on 10/3/06. The route of administration was not reported. The pt experienced a sudden onset of itching and rash at the injection site on 10/3/06. She required medical evaluation and was treated with Solu Medrol and Zyrtec. The recovery status of the pt was reported as unk. The reporter for this case is the same as for case 200602586. (OMIC)
Syncope, patient alert and responsive immediately following vaccination, but fainted a few minutes later while still seated. Patient attended to by companion accompaning him. No treatment given and recovered roughly 5 to 10 minutes afterward.
Chills, shivering, body discomfort, muscle aches, tenderness at injection, fatigue, loss of appetite.
Pt recvd vax on 7SEP91 w/HIB & 5 days later pt devel erythema multiforme, seen in office, CBC nl; tx w/ Atarax; next day had a fever, rash & was worse; CBC-nl differential, WBC800; 13SEP91, rash clearing but still febrile;
pulmonary embolism with chest pain symptoms on 4/9, improved with anticoagulation.  Patient also had laparoscopic paraesophageal hernia repair on  3/25 and so could also have been a provoked pulmonary embolism.