chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The client was given his shots today at 14:12 & I asked him to remain seated until we made appointments for next visit. At 14:15 he started to turn pale & leaned his head back. I asked if he felt OK & he said "I'm going to faint". I went to hold him in the chair while I called for help in getting the cot & some juice. His eyes rolled back, his hands clenched with arms stiff & outstretched, both legs stiffened & stretched out straight in front, both feet plantar flexed. He began rhythmically jerking his whole body & I put my hand behind his head to keep it from hitting the wall. The jerking & posturing lasted 45 seconds during which time I kept him in the chair. After it ended, he lost consciousness for 30 seconds. Once he regained consciousness we gave him juice & moved him to the cot with two person assist. We had him lie down & elevated his legs. His color remained pale-yellow, he was clammy & his pulse was 38 bpm. He was somewhat confused about what happened but was able to drink the whole juice box while lying down. He started saying "I had a dream while I was gone". His family & I asked what he meant by that & he said that he couldn't explain it but he knew he had had a dream & had "left" himself for awhile. He went on to say "I didn't get that spinny looking thing but I new I was leaving". His mom said that he had an episode of near-syncope when she checked his blood sugar one time & that he had seen "spinning" when it happened. She said that he's never fully fainted like today. I reassured that this can happen with adolescents & vaccinations. The client sat unassisted on the side of the cot for 5 minutes, during which time his pulse increased in rate to 58 bpm. He asked if they could leave & I made sure that he was steady on his feet. He left in the care of his mother & sister at 14:30 without further incident.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 61-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. The patient's past medical history included shoulder operation. Concomitant products included SHINGRIX. On 20th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient reported that he received the first dose of SHINGRIX in June 2018 at Pharmacy. In October or November of 2018, he had a flu shot in the same left arm and he reported that he felt like someone was standing over him and beating him up on his arm in the muscle at the injection site. The patient reported that he had shoulder surgery a few years back in his right arm that's why he received both shots in his left arm. The patient received his 1st and 2nd dose of SHINGRIX at different pharmacy. He claims that last evening his arm was really bothering him. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667916/1066Z) on 31-OCT-2012 that had expired on 03-MAR-2012. No adverse effects reported. Additional information has been requested.
I thought I was getting a cold, I had congestion, fever, chills, lost my appetite, I had a fever. I used a home COVID-19 test that came back wasn't really clear, I made an appointment with my doctor to go in to find out if it was the flu or COVID-19. I was tested for both COVID-19 and Influenza, the COVID-19 came back positive. I was at day five of my symptoms when I went into the doctor's office. I was given medication for my cough. It took three weeks for the nasal congestion to go away, the cough did go away in two weeks.
PATIENT WAS GIVEN IPV AND KINRIX ON THE SAME DAY.  NO SYMPTOMS REPORTED
Pt. described feeling as if her cheeks and front of tongue were slightly swollen. She also noted tingling of lower legs. She denied any throat tightening, no trouble swallowing or difficulty breathing, no chest tightness as she has experienced in exercise induced asthma. (Note: forgot to add under chronic conditions with only rare use of rescue inhaler).
Swelling under left armpit; Sharp pain; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 29Mar2021 at 08:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) of 81mg, loratadine (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 08:00 (at the age of 67-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 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 06:00, 48 hours after the shot, the patient experienced swelling under left armpit size of his open palm and sharp pain for four days till the time of reporting. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of swelling under left armpit and sharp pain were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccinated 19JUN08, pruitis/hives started on 20JUN08, 21JUN08 throat was swelling, was seen in ER, given IV meds (unknown), no admission, no residual problems.
pt recv vax & approx 10min later pt c/o redness @ site;entire deltoid red w/hives progressing to redness/hives extending across shoulder & down rt arm ice applied;referred to MD;
Patient broke out in hives, started swelling aroung the eyes mouth and face and began having difficulty breathing within 20 mins of being given both the flu and chicken pox shots.
Fever, fatigue, minor headache, severe chills, muscle pain, nausea, fast pounding heartbeat.  Rest, electrolytes, aspirin had an excellent outcome.
One day after receiving the second shot of the Pfizer/Biontech vaccine, I  woke up with complete numbness of of my left arm. I was unable to move that arm for about 1.5 hours. After that time, I regained sensation in my left arm again except that I now have weakness in my fingers and left hand.  I'm unable to make a fist, and hold certain objects as a standard cup of coffee without experiencing weakness in my left hand.  No prior medical conditions, no new medications or activities took place prior to the vaccine.
Heart rate over 100 for 6 hours, full body rash for 2 days, body rash returned after 3 weeks post vaccine and two further returns of the face rash on weeks 12 and 13 post vaccine.
got the Covid-19 virus; got the Covid-19 virus; breathing issues; This is a spontaneous report from a contactable consumer (patient's husband).  A 50-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine includes dose 1 of Comirnaty (at the age of 50-years-old). On an unspecified date, the patient got the covid-19 virus with breathing issues. The outcome of the events was unknown. Therapeutic measures were taken as a result of breathing issues which includes inhaler.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, chest pain, cough, headache, body aches, and low grade fevers shortly after vaccination. She was tested for COVID on ~4/2/21 and on 4/11/21, and both tests came back positive. Patient presented to the ER on 4/11/21 and was admitted for COVID treatment.
diarrhea; lightheadedness; dizziness; This is a spontaneous report from a contactable consumer(patient). A 93-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 09:45 (at the age of 93 years old) as first dose, single for covid-19 immunisation at School  Health Clinic. Medical history included hypertension, hyperthyroidism, osteoarthritis from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergy to paper and Dairy products from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), telmisartan (MICARDIS) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Patient was not received any other vaccine prior four weeks of vaccination. Patient received Amlodipine -10mg; Micardis 120mg; Synthroid 50m within two weeks of vaccination. Pfizer vaccine taken on Thursday 04Feb2021 at 09:45 and by Friday on 05Feb2021 at 14:15 afternoon had dizziness. Sunday on 07Feb2021 afternoon experienced lightheaded ness and on Monday 08Feb21 afternoon experienced dizziness and diarrhoea. Therapeutic measures were taken as a result of the events with Peptide Bismal. The outcome of the event was reported as not recovered.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Ipol was given yesterday to a patient, but it expired on August 2nd 2019, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old patient who was inadvertently vaccinated with an expired dose of 0.5 mL IPV (VERO) [IPOL] lot N1G511M via intramuscular route in unknown administration site (right dosterm was reported) on an unknown date which was expired in 02-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included- VARICELLA ZOSTER VACCINE (Flu vaccine) and VARICELLA ZOSTER VACCINE (Varicella).  It is an actual medication error case due to expired vaccine used.  At the time of reporting, the patient had no 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.  List of documents held by sender: none.
It was noted that the vaccine administered to the patient on 2/11/23 had a beyond use date of 2/8/23. It was still within expiration date window.
Hemophilia; missed second scheduled dose supposed to get at age 4 months due to fell off the grid, looking to get dose at 6 months; This is a spontaneous report from a contactable Other Health Professional reported on behalf of Nurse Practitioner via a Pfizer-sponsored program. A 4 months old male patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, batch/lot AL8456, Expiration Date: 31Jul2021), intramuscularly in left thigh on 11Feb2020 at the age of 10 weeks old at 0.5 mL, single for Routine vaccination and had no adverse reaction to first dose (as reported). Patient kind of fell off the grid and missed second scheduled dose he was supposed to get at age 4 months, looking to get dose at 6 months. Patient also had lab work prescribed at age 2 months which was not done. Patient was diagnosed with Hemophilia on 07Apr2020, but unknown onset date, or if patient developed hemophilia before or after first dose of Prevnar 13; but it was reported the patient's mom had Hemophilia. The patient's concomitant medications were not reported.  The outcome of hemophilia was not recovered.  Relatedness of drug to Hemophilia: Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Unrelated.; Sender's Comments: Hemophilia is unrelated to PREVNAR 13 use being a congenital coagulation disorder.
patient's girlfriend stated that patient got the vaccine on Thursday 4-1-21 and that he had to go to the ER on Friday 4-2-21 because he could not speak or walk. she stated that he had pain behind his right eye and blurred vision. she stated that one week later his doctor ordered a CT scan and determined that he had a stroke. spoke with the Nurse Practitioner at the office. she stated that the patient did have a stroke, but they did not know the cause of the stroke.   I am unable to get the lot number of the vaccine because it was entered through the state  system and the lot number did not go over. No lot number is associated with the vaccine.
Headache, Fever, NauseaVomiting, Chills Narrative:  Other Relevant History:
Rash spread to back & shoulders; Rash spread to chest; rash appeared on forearms; This is a spontaneous report from a contactable consumer (patient) reported for self. A 67-years-old female non- pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 at 14:30 (at the age of 67-years-old) as a DOSE 2, SINGLE for covid-19 immunisation at Public Health Clinic. The patient medical history included hypertension (High blood pressure), hypothyroidism (hypothyroid) and obesity (obese) all from an unknown date and unknown if ongoing. Concomitant medications received in two weeks included lisinopril (LISINOPRIL), levothyroxine, liothyronine (NP THYROID), berberine (BERBERINE) and glycerine monolaurate, inosine (MONOLAURIN [GLYCERINE MONOLAURATE;INOSINE]) all were taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 02:00 PM (at the age of 67-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. Patient had no Known allergies. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. The patient experienced rash appeared on forearms on 04Mar2021, rash spread to chest on 10Mar2021 and rash spread to back & shoulders on 11Mar2021, does not itch. No treatment was received for the event. Outcome of all the events were not resolved.  No follow-up attempts are possible. No further information is expected.
COVID-19 Positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 Positive) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (COVID-19 Positive). At the time of the report, COVID-19 (COVID-19 Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test (positive-negative): positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 test positive and COVID-19 symptoms after vaccination, this event is assessed as unlikely related to mRNA-1273.
Developed shingles 1 week after second vaccination. Erupted in left eye and traveled to area around eye on left side. Had 2 telehealth appts and got 2 prescriptions, one oral and one eye ointment. Lasted about 1 week. Mild case, thankfully.
Pt came into the Covid Vaccine clinic requesting his first covid vaccine. Per pt he came in yesterday and nurse noticed under immunization tab when reconciling immunizations two moderna vaccines are documented as external administration. Pt called yesterday and they were not able to resolve the issue apparently there is another pt with same name, last name and DOB. Pt would like to receive his first vaccine today. Spoke about issue encountered. Pt can receive vaccine today if he has not received COVID-19 vaccine in the past.
Stabbing chest and abdominal pain, nausea, diarrhea, fatigue, severe headache, body aches
myelitis (severe hemiparesis) treated w/systemic steroids was adm to hosp for a week;
Pt reported soreness 9/14/17, soreness continued to progress and now has limited mobility of left arm. Reports soreness is from shoulder to upper part of elbow.
vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown.  Information about lot/batch no has been requested.
Longer than Recommended Interval; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than Recommended Interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The patient had not gotten his/her second dose within the 6 month window, which led to lengthening of vaccination schedule.
pt recv vax 17AUG95 & & 4APR96 devel varicella w/93 pox on neck, face, arms, legs & genitals;it was reported as a vaccine failure;pt was treated w/hydroxyzine;pt was expose to varicella from an unvaccinated sibling
Breakthrough case of COVID-19. It started with a scratchy throat and headache. I tested positive on 04/14/2022. I was prescribed Paxlovid.
A serious spontaneous report of drug eruption manifested by rash that had small papules and scaly plaques has been received from a physician concerning a 48-year-old female, subsequent to FLUMIST. The patient's past medical history includes hereditary angioedema. Concomitant medications included cinryze. The patient received FLUMIST on 14-Sep-2009. On 21-Sep-2009, the patient experienced a rash that had "small papules". The patient stated that she had no rash during C1 esterase inhibitor infusion. However, on approximately one and half day after the C1 esterase inhibitor infusion, the rash worsened. On an unspecified date, the papules developed into scaly plaques that spread from her back to her trunk, then to her chest and finally to her upper arms and legs. On 05-Oct-2009, she underwent a biopsy and the results identified a drug eruption. The patient reported the rash was thought to be due to either the FLUMIST or a "lot of" C1 esterase inhibitor infusion. The reporter stated that the rash resolved and had not reoccurred.
Had the booster at 11:30am by 1:30pm I had a headache and injection site was sore. I had a low grade fever, shivers, chills, neck ache, body aches. I still have the headaches. Monday I started feeling a prickly feeling on the right side above my eye at the hair line. Went to see my doctor on Tuesday. I had pain and pressure behind my eye and ear all on the right side. Shots on my forehead. Also experienced blurry vision. 11/18/2021 I had a hard bump behind my right ear and lymph nodes are swollen.
First day I only had a sore arm Second day, typical malaise, flu-like symptoms Third day I saw improvement but still malaise. I tried a 500mg tumeric curcumin suppliment which was new for me ~5 hours later I noticed brain fog and my vision was not as clear. Over the next 3-4 days my brain stem/back brain started to throb/vibrate occasionally, and I got very bad tinnitus.
t101.5 during nite 15jUL-16JUL t101 AM 17JUL92; 14JUL92 t101 8PM;
Drumming in left ear/Tinnitus starting 4/30/2021 5/8/2021 Muffled hearing left start and stays. Ear drumming loud stops 5/8/2021. Basic Tinnitus static starts. 5/8/2021 blood in stool starts 5/9, 5/13, 5/14 and 5/15 saw doctor Hemorrhoids present. never had bleeding from hemorrhoids ever. 5/15/2021 Had a horrible migraine both ears went muffled and horrible pain starts. Also developed on and off sensitivity to touch of scalp. When I touched my scalped it felt like extreme pain. Hyperacusis, sensitivity light and nausea present on and off till present. Left and right ear fullness and pressure still to present. Issues with hearing because of fullness and pressure. Neck and shoulder pain present since 1st dose. On and off Migraines and pressure headaches still to present. Brain Fog present