chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client came to office for first COVID 19 vaccine, requested MODERNA- signed paperwork for consent and checklist denying he ever got the vaccine and verbally stated to me that this was his first dose of the COVID vaccine of any kind . It was given as stated above and as he waited the 15mins ( which I increased to 30mins) I entered the data into the Immunization information system when I noted that his name and DOB came up with already vaccinated with Moderna at health services in March and April. Upon confrontation he denied it still; but after extensive education on the dangers of such actions and more appropriate ways to not get Covid variant he stated he would not get a forth.  He had no reaction and he left stable.
Patient reported local pain which subsided over following days, but starting 09/13/2019 area began to be red, inflamed and warm to touch. Patient presented to pharmacy on 09/16/2019 with area red, inflamed and warm to touch. Patient denied any issues with breathing or swallowing. Patient advised to contact MD.
Vaccines rec'd 2 days ago, 1 inch apart on LLT, KINRIX at upper site and MMRV at lower site. At todays visit 11/22/13, site was 2.5" x 3" erythematous raised, warm to touch area of skin. Local only. Tender to touch, walking normally, no fevers.
Patient was given Moderna Bivalent as a second covid vaccine. Patient did not complete the initial series of Pfizer covid vaccine prior to this given.
Headache, pain, redness and swelling at the injection site, followed by fever and chills ,myalgia
Client reported feeling nauseous to RN after receiving the Fluarix Quadrivalent vaccine. RNs responded. RN noted the client appeared pale and was holding an emesis bag provided by RN. The client stood up and transferred to the anti-gravity chair without assistance. The anti-gravity chair was placed in a semi-fowler's position. RN noted trembling of the client's legs bilaterally. RN offered the client water or juice and the client declined. RN provided the client with a cotton swab with peppermint oil on it and the client began smelling the peppermint oil. The client then agreed to take a small sip of juice. The client stated she did not like the juice. The client's mother reported the client ate an egg sandwich this morning. The client and her mother denied any chronic conditions, medications, or known allergies. The client's mother reported that the client has a history of feeling nervous when receiving vaccines and "other situations." Vitals obtained with the pulse oximeter at 12:31PM were as follows: HR 80 and O2 97%. The client stated that she was feeling better, denied any current nausea, and reported persistent trembling. Vitals obtained at 12:35PM were as follows: BP 110/79, HR 76, O2 99%. The client ambulated unassisted with a steady gait to the observation area at 12:38 PM. The client sat in the anti-gravity chair in the observation area. The client began drinking water. Vitals obtained at 12:45 PM were as follows: BP 122/77, HR 96, O2 97%. Vitals obtained at 12:51 PM were as follows: BP 146/79, HR 78, O2 99%. Repeat blood pressure taken at 12:54PM was 108/70. The reported feeling "sleepy" but denied any other symptoms. RN provided education regarding s/s of anaphylaxis and when to seek EMS. The client and her mother voiced understanding of this education. The client ambulated with a steady gait out of the vaccination site at 12:55PM.
This case was reported by a healthcare professional via a sales representative and described the occurrence of red spotty (injection site) in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX in an unknown thigh.  At an unspecified time after vaccination with KINRIX, the subject experienced red spots at the injection site.  The nurse reported that she instructed the subject to apply a cold compress to the injection site.  At the time of reporting the outcome of the event was unspecified.  It was reported that this event occurred in 4 additional subjects.  Linked case numbers included A0803829A, A0803832A, A0803834A and A0803835A.
sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours; swollen lymph nodes left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included heart disorder (heart disease), hypertension, and obesity. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient received other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sever joint pain hands, arms, shoulders, extreme fatigue, nausea, muscle fatigue, chills (for 6 hours as reported), swollen lymph nodes left side all on 23Jan2021 02:00 with outcome of recovering. The patient did not received any treatment for the events.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # J013394, expiration date: 25-AUG-2016 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
The day after receiving  the vaccination and also starting oral antibiotic  (Bactrim), I became extremely ill with fever, severe nausea and dizziness.  These symptoms lasted for five days and caused me to lose 10 pounds of body weight and fall down numerous times. I also had episodes of delirium.  The Bactrim was prescribed for ten days, but I ceased taking it after five and on day six my condition improved dramatically.  I had the second dose of Shingrix  on 16 January with no adverse reactions.
Red streaks on arm below area; This case was reported by a consumer and described the occurrence of erythema of extremities in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The caregiver reported that the patient received a dose of Shingles vaccine and had red streaks on arm below area. The symptoms were not treated. The reporter consented to follow up.
Case number PHEH2014US018544, is an initial spontaneous report received from a consumer (patient) on 12 Sep 2014. This report refers to an adult female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscular on 09 Sep 2014. The patient reported that her arm swelled up the next day on 10 Sep 2014. Pharmacist told her to take ibuprofen. She still had a quarter red spot at the injection site and it was a little sore. She had a high tolerance for pain, but it was hurting a little bit. Final outcome of the events, seriousness and causality assessment was not reported.
1222PM nurse approached pt. noted with pallor and uncomfortable posture. Patient reported nausea. Pt reported she felt "weird" after the vaccine administered. MD approached and assessed patient. no diaphoresis, no fever, no chills, no reports of blurry vision, no swelling of throat or arm.   1223 pt was rested on ground with feet up on chair. No past medical history. No more reports of lightheaded when laying down. Reports having food. No history of allergies and Doctor states likely to have vasovagal response. Pt reports taking delaxine 2% ointment. No issues in first 2 vaccines. She experienced nausea and feeling hot immediately following vaccine.  1229 color returning to face while supine. nausea subsided an no dizziness or lightheaded.  1232 sat up with no issues. sat into chair with assistance. reported feeling better.  1236 cleared by doctor. no weakness and color back.  left ambulatory.
Approximately 36 hours after injection I  became dizzy, could not sleep due to constant dizziness, off-balance and found it difficult to rise from a sitting/laying position without being overcome by dizzy spells.  Also felt slight tightness in my head.  I begin to take my blood pressure which was well over what was normal for me.  BP ranged from highest of 155/84 to 145/78.  Blood pressure begin to lower as I begin to take my Blood Pressure medication doubling the dose from 5mg to 10mg Amlodipine. I also take the medication at night, versus my normal routine to take medication during the day.  Not sure if this was just a coincident or precipitated by the vaccine.
I woke up Wednesday morning sneezing and runny nose with a little itchy eye. Had sore throat from drainage. I took a home test that was positive. Went to doctor on Thursday he did a rapid test, and it was positive. I felt better within 24 hours. Because of my age and because I have asthma doctor prescribed me 5 days of Paxlovid.
8 hours later, arm was numb/asleep and ice cold, sat up and started to feel better. Woke up in the morning with  headache, fatigue, dizziness continued for 2 days. 3rd day , right hand was ice cold, it comes and goes. Took Benadryl and it works for about an hour then it wears off.
Possible seizures (repetitive head turning and possible salaam seizure) occuring Jan 14, 2009 over a 10-15 minute time span. No fever at that time, otherwise not ill at that time. No treatment. Evaluation still in progress (EEG, Peds Neurologic consultation)
Insomnia starting night of 4/19 , then starting 20 dizziness headaches vertigo, increase joint pain  chills, loss of appetite, digestion got worse. Rash development on shoulders chest and stomach 4/24
Pain under my left arm and down through my left arm, eventually moving into my chest and into the right side of my neck.  It seemed to be in my glands.
Neuropathy pain was greatly heightened, continual for 1-week, and more persistent currently.  Leg continues to be numb.
fever of 101.8; chills; joint aches; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever of 101.8), CHILLS (chills), ARTHRALGIA (joint aches) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for an unknown indication.     The patient's past medical history included No adverse event (No medical history reported).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (fever of 101.8), CHILLS (chills), ARTHRALGIA (joint aches) and HEADACHE (headache). At the time of the report, PYREXIA (fever of 101.8), CHILLS (chills), ARTHRALGIA (joint aches) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Pt stated few hours after vaccine she started to fee feverish, had aches and pains and broke out into hives. She took TYLENOL OTC and rested for few days and felt better after that, no medical attention.
Right Arm injection: Soreness at the injection site, difficulty lifting my right arm in any direction.  The discomfort continued and worsened over the past 5 months with no improvement.  No medication was taken such as acetaminophen or ibuprofen, for the discomfort.  Reported the problem to my medical caregiver, but was told it is not unusual.
Got Pfizer Covid vaccine dose #1: 3/15/21 and I developed a headache by the time I arrived home. Headache was 7/10 pain minimum, lasting a week almost non stop. The headaches had a  vascular feeling/pounding - worse with getting heart rate up or position change, increased temperature, and were not like any headache I have experienced before. I do not get many headaches in general but I had never had one like this- the quality was very different. H/A Started getting less intense after a week- were down to about 4/10 and more intermittent.  They got progressively less frequent and less intense until they mostly stopped in early- mid May.  They would come and go without warning and when they went away would go away also without warning.  Since May I have experienced them 1-3 more times with the same sort of quick onset without warning.  After dose 1 I also had mild chills, fatigue, and achiness but I don't consider that an adverse event.
ADMISSION: 10/20/2021:  95-yo F w/ PMH of T2DM,  HTN, HLD, left shoulder rotator cuff tear, and pancreatic mass (?serous adenoma--no further work up was decided w PCP).   She p/w being found down w/ confusion this am @ 8:30 at her Facility, still in yesterday's street clothes.  drove the pt to an apptmt early yesterday afternoon when she received a left shoulder injection.  She had a "coughing fit" in the car enroute and also slept x 45 min on the way home.   The pt had very little recall of yesterday's events for me but she had reported to the ED MD that she went out to check her mail yesterday evening and when she returned she tripped and fell and was unable to get up---so slept on the floor overnight. She reports pain in her left shoulder with decreased movement today, also of let 2nd toe nail pain.   PT CONTINUES TO BE AN INPATIENT.
It was reported in a published article, title as stated above that 6 children experienced true vaccination failure and developed invasive Hib disease, also referred to as meningitis, despite completing the primary series and receiving a booster dose of PedvaxHib (manufacturer unknown) after one year of age. None of the patients had any risk factors. No further information was available at the time of this report. No outcome information was reported. Upon internal review, invasive Hib disease/meningitis was determined to be an other important medical event. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
pt started feeling light headed and sweaty within 5 min of vaccination. pt didn't report symptoms until 2 hours later, when she was given 25 mg of diphenhydramine. then she was being monitored every 60 min for changes
Headache, Myalgia, pain to inj site and shoulder; headache, chills, body aches Narrative:  Day 2- pain to inj site and shoulder, headache, chills, body aches
PAIN/PAIN IN BODY; FEELS COLD; PAIN IN MUSCLES; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced pain/pain in body. On 02-APR-2021, the subject experienced feels cold. On 02-APR-2021, the subject experienced pain in muscles. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, pain/pain in body, feels cold, and pain in muscles. This report was non-serious.
Pt recvd DTP/OPV @ 2PM 2 hrs p/this had a generalized sz lasting about 10 minutes;
Approximately 22 hours after PPV23 vaccine patient C/O headache, left upper arm pain, left upper arm swelling and diffuse joint pains. No treatment, patient took naproxen at home.
Immediately following the vaccination, I had some site pain. I felt tired that evening and went to bed early, sleeping well (Wednesday night). Approximately 20 hours after receiving my 2nd vaccine (10am Thursday), I developed a low fever (99`), extreme lethargy, chills, and overall body aches. These symptoms lasted approximately 13 hours. When my fever broke (approximately midnight Thursday), the body aches and chills went away as well. The next day (Friday), I woke up to significant arm pain, severe headache, tingles in my arm, swollen lymph nodes in my arm pit and neck, as well as a rash on my upper arm around the injection site. These symptoms persisted until Sunday. The rash and swollen lymph nodes disappeared Sunday night/Monday morning. Since Monday, however, the headaches, arm pain, and some tingles in my arm have persisted all week. Motrin curbs the pain of the headaches and arm pain, but as it wears off the pain resurfaces.
Arm pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Arm pain) and FATIGUE (Fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included LEVONORGESTREL (KYLEENA) for Birth control, LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (Arm pain) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 UNK and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (Arm pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes fluids.   This case was linked to MOD-2021-044522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Significant follow up was received on 07-june-2021 patient medical history, concomitant medication, demographics, second  dose details was updated
accidentally received an ACTHIB vaccine that expired on 04OCT2021 with no reported adverse event; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer non health care professional via Medical Information (MI) number: 00809297.  This case involves a one years old female patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, medical treatments, vaccinations, and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ404AA and expiry date: 04-OCT-2021 via intramuscular route in unknown administration site for prophylactic vaccination.  At the time of reporting, no adverse event was reported.  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.
Patient received the vaccine Monday morning on the 29th. Mom gave pt some Ibuprofen right after vaccination due to the patient saying his arm was sore. Patient's arm itched Tuesday at school. Tuesday night Mom noticed the swelling and redness of arm. She drew a line around the swelled/red area on arm Tuesday night and gave him 10ml of liquid Benadryl at 9pm. Wednesday morning (10-31) Mom gave pt another 10ml of Benadryl liquid and noticed that the swelling had spread past the original marked area. The swelling spread down the arm and along the inside of arm towards the armpit. This was verified by pharmacist and recommended Mom take pt to see provider. Mom took pt to see a doctor and received a prescription for prednisolone 15mg/5ml (10ml by mouth once daily x3 days).
The night of the second shot I had joint aches, slight chills, fatique (which lasted for 2 days), Friday, March 5 around 4:30pm I started to itch, and noticed welts appearing everywhere on my body,  now 8am on Saturday, March 6 the hives are still showing up, itching is horrible with no end in site.  I am trying to avoid an emergency room visit for this sympton, have not seen it listed anywhere.   My neighbor experienced the same thing but hers was the day after her second shot, the only common denominater is the shot.
Local Reaction o L arm tenderness, numb 24 hrs, which resolved   Systemic Reaction  o new headache described as mild, nausea, vomiting 3d, dizziness, fatigue: all sx on/off 1 d post vaccine
Pt received PREVNAR 13 at aprx 2pm. At aprx 3am, pt woke up with tongue swelling, entire arm redness, itching and pain.
The day after the shot, the patient reported her arm being swollen, warm, red, and painful.  She reported it started itching on 11/19/2016.
Patient received vaccine at 12pm on 04/23/2021. At 3pm the patients arm started going numb with difficulty moving her arm. At around 6pm her body started going numb and she had difficulty moving and had to go lie down. She also had difficulty breathing and had to use her inhaler. She took Tylenol, Ibuprofen and Benadryl. The symptoms continued through out the night and the next morning she started feeling better and could begin moving around. She still had difficulty breathing and had to keep on using her Albuterol inhaler. The following day the could move around better but was still short of breath. Patient was advised to contact her PCP if symptoms doesn't keep on improving.