chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received booster instead of third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster instead of third dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 027L20A and 031L20A) for COVID-19 immunisation.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included Reaction hypersensitivity (NOS) with flu shot. Concurrent medical conditions included Immunocompromised and Sjogren's. Concomitant products included LEVOTHYROXINE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster instead of third dose). On 17-Nov-2021, ACCIDENTAL UNDERDOSE (Received booster instead of third dose) had resolved.            On 13jan22 COVID19 IgG serum: negative, that is why the rheumatologist told her to take another dose. Patient reported within 30 minutes of getting the vaccine: head full, upper lip tingly  Patient to ER: heart beat and pressure fine, lungs fine. Gave her a steroid and Benadryl shot. Patient took treatment steroid and Benadryl shot.   This case was linked to MOD-2022-472923, MOD-2022-473001 (Patient Link).
Information has been received from a medical assistant concerning a 12 month old male with no pertinent medical history and no drug reaction/allergies who on 18-JAN-2011 was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot# 668597/1181Z; exp date unknown). There was no concomitant medication. On approximately 24-JAN-2011 ("last week"), the patient had been diagnosed with chickenpox. The patient had 2 lesions on the back, 3 lesions on the head, and 2 lesions in the diaper area. The patient had 1-2 lesions of the 7 lesions that had scabbed over. There was no treatment given for chickenpox. There was no lab diagnostics studies performed. At the time of the report, the patient was recovering from chickenpox. The patient visit the physician's office to seek medical attention. Additional information has been requested.
Macular rash on wrists and hands requiring the administration of Benadryl, as well as complaints of "a headache in the back of my head".
Injection site feels like it is lumpy; strong injection sitesoreness.; This is a spontaneous report from a contactable consumer, for patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal) and arrhythmogenic right ventricular dysplasia. Allergic history was not reported. Concomitant medication included famotidine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 31Mar2021, the patient experienced lump at the injection site with no visible inflammation and had strong injection site soreness. 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 events. The clinical outcome of the events vaccination site mass and vaccination site pain were resolving at the time of report.    No follow-up attempts are needed. No further information is expected.
9YO received Infanrix instead of Boostrix; 9YO received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 9-year-old male patient who received DTPa (Infanrix) (batch number PAK443, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 21st September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The licensed practical nurse called to inquired that any recommendations or guidance or how to proceed. The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Infanrix instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
FEVER POST VACCINATION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced fever post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever post vaccination was not reported. This report was non-serious.
Information has been received from a registered nurse via a field representative referring to two female patients of unknown ages. On unspecified dates approximately in 2015 (reported as "sometime in the last few weeks") the patients were vaccinated with GARDASIL, strength and dose number of the 3 dose series unspecified; 0.5 ml once, intramuscularly. About the same time, the patients were also give concomitant therapies included TD ap and meningococcal vaccine (unspecified). ON unspecified dates in 2015 the patients experienced severe nausea after receiving the GARDASIL vaccine. The outcome of nausea and the causality were not provided.This is one of several reports received from the same reporter. Additional information has been requested.
On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, chest tightness, diarrhea, feeling of something stuck in her throat globus sensation, weakness.   She went to the ER on 1/18/21 they felt she had gastritis and gave her fluids, Zofran and COVID test which was negative, then they sent her home.  It continued where she could not eat, could not sleep, felt like she was going to die.  She ended up going back to the ER again on 1/23/21.  They did a CT scan, EKG, gave her IV fluids, flu and an antimotility agent for the nausea.   They did lab work to rule out other tests.  Did stool culture, blood work.  She got admitted over night, then she had endoscopy on 1/24/21 to rule out any issues with her throat since she felt like it was closing on her.  They said her esophagus looked fine, took biopsies.  All the tests that were done were negative, and sent her home on 1/24/21.  Then on Monday, 1/25/21 went to see a ENT specialist who also did a scope to loop down her throat to se if anything was blocked and felt that it was inflammation due to vomiting.  Advised to take Proton pump inhibitor to help with the acid reflux from the vomiting.  The GI doctor called on 1/26/21 showed some H-pylori, but did not know why she had that.  Was started on antibiotics for that.  She saw her PCP on 1/28/21, who did work up for celiac disease, thyroid scan/studies and all tests were negative as well.  Right now she is home and the plan is to wait it out and to see if she gets better over time.  She still having today 2/3/21 diarrhea, no appetite, cannot sleep, occasional chills, no fever, headache, chest tightness, nausea but is taking Zofran, still having the globus sensation in her throat.  States her "body is not well", weakness as well.
Pt reports intermittent brain fogginess since having the vaccine. It has not resolved in the 3 months since administration.  He also reports increase nausea since the dose.
Received Adacel 6/19 and began with side effects on 6/20. Reports headache, vomiting, muscle aches, fever, swollen neck gland, site red, tender and swollen. Fever 100.
By the end of the week after vaccination that is when I noticed my hair was falling out. My nails broke off shortly after but I didn't put two and two together. I had to have fluid taken out of my knee on April 5 and then went again June 8th. I had to have injections in my left shoulder, my next injection is scheduled on March 3rd. I started being seen for my right thumb for severe pain; had injection in July and I now need to have surgery. My hair is so thin that I can't cut it short because pieces are missing everywhere. I had none of these issues prior to my shot. I used to see my doctor once a year only. My doctor put me on iron pills 2 x daily to help with my hair and nails.
Well child on 6/4/01 and received 3 vaccines. Was well until 22:00. Went to sleep and did not wake up. Evaluated at 11:00, in the clinic and could not be aroused. Sent to ER and he slowly woke up spontaneously. Recovery seems to be complete. Spiked temp of 105 degrees
9 hrs after injection - chills and mild headache.  Took ibuprofen and slept. 20 hrs after injection - extremely minor chills.  Took ibuprofen and symptoms faded without returning. 44 hrs after injection - swelling under left arm (likely swollen lymph nodes) which is in close proximity to the site of the injection (left arm) Now: 96 hrs after injection - swelling under arm remains persistent without worsening or subsiding.  Does not impede use of arm.
Dizziness, Sedation, Diarrhea & Nausea Vomiting Narrative:
Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored PROQUAD (lot # M021428, expiration date 29-OCT-2017; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, duration of temperature excursion): 26-NOV-2016, 6 degree Fahrenheit (F), 6 min 26-NOV-2016, 7 F, 6 min 26-NOV-2016, 8 F, 6 min 26-NOV-2016, 9 F, 9 min 26-NOV-2016, 10 F, 4 min 25-NOV-2016, 6 F, 10 min 24-NOV-2016, 6 F, 8 min 24-NOV-2016, 7 F, 6 min 13-NOV-2016, 7 F, 8 min 13-NOV-2016, 6 F, 7 min 12-NOV-2016, 6 F, 10 min 12-NOV-2016, 7 F, 7 min 12-NOV-2016, 8 F, 10 min 06-NOV-2016, 6 F, 8 min 06-NOV-2016, 7 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 7 F, 6 min 04-NOV-2016, 8 F, 7 min 04-NOV-2016, 6 F, 6 min Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063:
swelling in the right arm; Right arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the right arm) and PAIN IN EXTREMITY (Right arm hurt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Drug allergy (Thimerosal) and Allergy multiple. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE FUROATE (ARNUITY ELLIPTA), MONTELUKAST, CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) and LORATADINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in the right arm) and PAIN IN EXTREMITY (Right arm hurt). In March 2021, PERIPHERAL SWELLING (swelling in the right arm) and PAIN IN EXTREMITY (Right arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other Concomitant medication includes ZATIDOR eye drops during allergy season. No Treatment medications were reported.   This case was linked to MOD-2021-284124 (Patient Link).
have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (have some past expiration administrations that have surfaced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (have some past expiration administrations that have surfaced). On 02-May-2021, EXPIRED PRODUCT ADMINISTERED (have some past expiration administrations that have surfaced) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-392091, MOD-2021-392110, MOD-2021-392115, MOD-2021-392117, MOD-2021-392129 (Patient Link).
Spotting one day after shot and now 3 days after moderate vaginal bleeding. I have an IUD so I do NOT get periods or have vaginal bleeding.
pt recvd vax & approx 5-6 days later, pt devel f to 104; chills; sweating & d; cbc revealed low wbc of 1.8; low plt ct of 18,000 & hgb of 8.8; spleen & liver enlarged; tx atb for 7 days; MD states symp typical of brucellosis;considering atb
Large ground raised red area around shot site the size of a Silverdollar sore arm for two days and headache.  then no pain itching or warm to touch at site 2 days after shot... 15 days out still same large red area at shot site .. still somewhat raised  Has not changed since first appeared
On 12/24/12 patient reported that her arm hurts at the injection site as well as under her arm. She said she was going to see a Dr. On 12/26/12 I called her and she said she was better - no pain or discomfort.
Pt is experiencing soreness and redness on her right arm after receiving a Pneumovax 23 Vaccination
Janssen on 5/5. Positive on 8/26 ADMITTED 8/24 TO CURRENT
Hep B vaccine #1 given 8/11/04- By 8/16 developed sx of daily nausea, epig pain, diarrhea (not watery, but soupy stools) 4x 1 days feels brown or green, feels fatigued seen 9/7-WT stable-NAD-exam neg- no jaundice- mild tenderness RVA + epig. Labs ordered- Hep panel, LFT, CBC diff, ESR-BMP. Stool C/s. O+P-RBC, WBC. BoPhenergan, dietary A's.
Client received first dose of the COVID-19 vaccine Moderna on 08/24/2021.  Client returned  on 08/25/2021 (the following morning) with facial and lip swelling and arrived cursing at the security staff of building at 10:45 AM. Lead Nurse spoke to client at 10:53 AM outside  on 08/25/2021 and recommended for client to seek medical attention due to bilateral lip swelling. Lead Nurse offered to call 911 for client numerous times but client  declined. Lead Nurse  remembers client was scared about his facial and lip swelling. Client left the premises on his own free will at 10:59 AM.  Client returned on 9/23/21 and Nurse Co Lead spoke to client for second dose medical consult. Client stated he experienced generalized facial swelling and bilateral lip swelling that began the next morning after receiving first Moderna vaccine dose. Exact time of symptom onset was determined to be unknown. Client verbally stated, "My entire face felt numb like when you go to the dentist, I just woke up like that." Client denied swallowing and breathing difficulties. Swelling duration lasted 1 day and self resolved.
Patient began to experience dizziness around dinner time on date of vaccination.  Later in the evening patient began vomiting and had extreme fatigue, reports she was in bed Friday, Saturday, and Sunday post-vaccination.  Vomiting lasted approximately two days, dizziness and fatigue all three days.  Patient reported she felt poorly enough she would have gone to the ED actually but did not have anyone to take care of her pets had she been admitted.
See previous ?short term illness?. Super red itchy arm growing in size daily. 11 days after injection still itchy and growing. 3x4 inches in size and circular.
On 11/17 I started having abnormal vision and having trouble speaking. I drove myself to the ER where it was determined that it was a migraine. I had a CT scan; EKG and ECG. I was referred to a Retina Specialist as I had fluid in my eye. I have had one injection of LUCENTIS directly into my eye. And will most likely have a second injection when I have a follow up appointment with the Retina Specialist on 01/04/2023. I have seen an Ophthalmologist; Retina Specialist and all have contradictory diagnosis for my condition. I also have a follow up with the Ophthalmologist as well.
Immediately upon receiving the injection, she felt  like her arm was asleep and had a numb tingly feeling.   Numbness/tingly feeling in her left arm down into her fingertips.  She also felt woozy.
Itch in the injection site; A spontaneous report was received from a consumer concerning an 87-years-old, female patient who experienced itch in the injection site.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient experienced itchiness around the injection site after vaccination. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event itch in the injection site was unknown.
Immediate severe pain after vaccine was administered way too high on the arm resulting in tremendous pain that continues 15 days after shot thus resulting in inability to sleep and use arm / no prior shoulder problems ever before vaccine / Nurse was standing I was seated very low and she pushed down to administer shot / band aid was applied on top of side shoulder / it felt like she had "hit something" upon penetration of needle / pain worsened after leaving hospital / ibuprofen / alka seltzer / heating pad are all being used for pain treatment day & night / no redness no / no swelling pain is inside not out / hurts when laying flat.
Seizure - onset approximately 1 hour after vaccination administration. No medical history of seizures. Duration estimated 3 min - myoclonic head jerking, eyes rolled back, cyanosis
On the 10 th day after vaccine arm began to itch and burning with a round red patch . About 2 inch in diameter. Was better in two days . Then The burning has return on day 14 and again on day 16th after first shot. Don?t have a rash, just burning sensation.
This case was reported by a pharmacist and described the occurrence of fever in a 44-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 11 July 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route). On 11 or 12 July 2012, less than one day after vaccination with BOOSTRIX the subject experienced fever and chills. In July 2012, the events were resolved within 3 days. The pharmacist reported two subjects were vaccinated on the same day with same lots of BOOSTRIX at the same pharmacy complained of fever and chills with onset within 1 day of vaccination and resolution within 3 days. See case A0987453A for details regarding the other subject. On 08 August 2012, updated lot number information was received from a safety review. The lot number was reported as A152B078AA from the reporter; however, based on safety lot number review, the lot was updated to AC52B078AA.
10/26/00, 6 month visit vaccines given. On 10/27/00, Mother described a 15 second spell of shaking arms and legs with eyes rolling back in his head, followed by loss of tone. Child then normal. Seen on 10/27/00.
My menstrual cycle was delayed for 10 days; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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. The concomitant medications were not reported. On 04May2021, the patient's menstrual cycle was delayed for 10 days. Therapeutic measures were not taken as a result of the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle was delayed for 10 days was resolved on an unknown date in May2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dizziness, nausa, headache, weakness, tired.  slept all afternoon.  Some better in eve.  today, 2-21-21, after sleeping 11 hrs, Much better.
I woke up in the middle of the night several times very uncomfortable with aches and pains. Aching, low grade fever, headache and very lethargic.
Within minutes of administering Tdap and Hep B (first dose), patient admitted feeling dizzy and proceeded to get pale in color.  PHN asked patient to move to floor in laying position, and half way down patient fell to floor and went unresponsive for about a minute.  Patient then became responsive and stated his face felt numb, and he continued to look pale.  PHN administered .3ml of epinephrine SQ, oxygen administered and transported to local emergency room via ambulance per protocol.
ACUTE NON ST ELEVATION MI ACUTE MI 12/8/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient in the 30 minute wait time had an allergic reaction to the vaccine. She had an reaction that caused her tongue to swell and produced slight itching. Patient presented for Second dose with Epi-Pen and Benadryl. Doctor determined that based on first dose reaction it was not safe for her to attempt the second dose. Second dose of vaccine was not administered.
Sore arm, fatigue, swollen eyelid on the opposite side of injection site.
Box 18 - Woke up in the middle of the night disoriented. Didn't know where I was. First time I've experienced this type of reaction to anything. No medical attn. sought. Advised against receiving 2nd dose per Dr.