chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 minutes after receiving the vaccine, patient reported feeling dizzy, nauseous, and had tingling of her left arm (vaccine was given to the right arm).  At the time of event her BP was 142/75, HR 76 and RR 20. Patient was placed in a first aid room and after 15 minutes she reported she was feeling well. She was able to sit up and drink some water. After another 15 minutes she said she felt well enough to leave. She went home with her husband
PATIENT JUST REPORTED THIS ADVERSE REACTION TODAY, 2 MONTHS AFTER THE VACCINE. HE EXPERIENCED RED, SWELLING AND SORENESS IN LEFT ARM AT SITE OF INJECTION. BEGAN 2 DAYS AFTER VACCINATION AND CONTINUED FOR ABOUT 3 WEEKS. IT CAUSED NUMBNESS IN LEFT ARM AND HAND, AND NUMBNESS CONTINUES ONLY WHEN PATIENT LIES DOWN. THIS NUMBNESS CONTINUES NOW EVEN AFTER SWELLING RESOLVED.
Bleeding in my urinary tract for which they found a clot in my bladder the catheterized me to clear up blood
A 72 year old male patient received a left arm injection of TD ADS adult, lot number U1022AA, on Jan 12 2005, after stepping on a nail and injuring his left foot. Route of administration was not reported. Eight days later, the patient developed left arm swelling, had spasms of his arms and tics and hand tremors. He was examined by a physician. An electrocardiogram was performed although date and results were not provided. Pre existing medical conditions were reported as none, and other medications include aspirin daily. Per the reporter, the spasms continue. At the time of this report, the patient had not recovered. The reporter indicated that the event was previously reported to VAERS.
Experienced Dizziness after the Pfizer vaccine. I waited 15 minutes on site and experience the dizziness  the entire time. I left after the 15 minutes and still had slight disorientation.  After 30 minutes I fell normal.
her lower back started hurting; It makes her feel like throwing up; She got chills and aches 14 hours later; She got chills and aches 14 hours later; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she got her first dose on Wednesday (as of 05Apr2021). She got chills and aches 14 hours later. She reported that on "this Saturday" (as of 05Apr2021) her lower back started hurting, also reporting it made her feel like throwing up. The outcomes of she got chills and aches 14 hours later, her lower back started hurting and it made her feel like throwing up were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
patient presented to emergency department on 11/21/21 with shortness of breath and cough patient was admitted for further management of covid-19 patient was found to be covid-19 positive on 11/23/21 patient received dexamethasone and remdesivir  patient was discharged to home on 11/29/21
Patient was administered with expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/ vials administered 13doses from 2 vials. Date the vial was initially stored in the refrigerator was unknown. The vial had not undergone any temperature excursion.  No treatment medications were reported.
Patient presented to the ED and was subsequently hospitalized for gastroenteritis and dehydration. He also was admitted on 3/15/21 for below the knee amputation due to recurrent cellulitis.
body aches; CHILLS; fever; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (CHILLS), PYREXIA (fever), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021 at 2:00 AM, the patient experienced PAIN (body aches), CHILLS (CHILLS), PYREXIA (fever), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, PAIN (body aches), CHILLS (CHILLS), PYREXIA (fever), ARTHRALGIA (joint pain) and HEADACHE (headache) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter.
stood up quickly and felt a couple of waves of lightheadedness and swaying; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old female (Non pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205, expiry date: unknown), via an unspecified route of administration, administered in arm Left on 07Mar2021 at 14:00 as a 1st dose Single Dose for covid-19 immunization. The patient past Medical history included Sulfa allergy. Patient Concomitant medication included Ascorbic Acid (VIT C) and cholecalciferol (VIT D3). No prior vaccination was received and tested for positive before vaccination. No other vaccination was received within 4weeks.  It was reported that she felt great immediately after but approx. 95 minutes after she was putting groceries on the bottom of her freezer. she stood up quickly and felt a couple of waves of lightheadedness and Swaying on 07Mar2021 at 03:30 PM. Held the counter until it passed then went a sat down for a few minutes. No treatment was received. The outcome for the event was Unknown.  No follow-up attempts are possible. No further information is expected.
I can't taste anything; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021, the patient ate breakfast, felt everything was fine and then had another small breakfast and suddenly was not able to taste anything. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
10:28 am - Client reported dizziness and light headiness. Client vomited after receiving vaccination.
Left arm soreness followed by nerve pain in bilateral upper extremities, upper mid back pain, chills, headache, weakness.  Alternating tylenol and motrin only mildly effective.  Greater than 24 hours s/p injection, continued headache, nerve pain.  Approximately 40 hours later developed raised measles like rash bilaterally above the knee and distal upper extremties (forearms), flushed face and eat lobe swelling.  Some improvement with 50mg oral benedryl and 1000mg tylenol.  If no symptomatic improvement, will seek urgent care for prednisone
Patient called health dept on 5/25/21 at 2:30 pm and spoke with, RN. States she received TDAP on 5/12/21 but on 5/20/21, she developed swelling and pain to rt arm but no redness. States she is being evaluated by MD tomorrow.  Called Glaxo Smith Kline and noted  prefilled syringe tip covering only has latex but not  plunger. Unsure if this is related to latex allergy.
First: Headache, Pain at Injection site. Second: Fever for several hours at a time, shortness of breath, Nausea, Chills The second set of symptoms persistent off and on for 72 Hours and only started to get under control after experiencing them for more than 24 hrs.
enough to go in. I explained the course of illness to his pediatrician and stated that it appeared he was having a reaction to the MMR vaccine. She was quickly dismissive of this idea and gave a long explanation about how teenagers notoriously ignore signs and symptoms of illness for so ling that they can develop a fever to finally force them to stop all activities and rest. She then stated that it sounded like he was ill with the flu. I informed her that we had been through at least 5 flu illness with our son and he had never manifested any like this. I questioned the severely delayed fever and joint pain. Again she tried to reassure by diagnosing this as the flu. Our son continued with a low grade fever for that I explained the course of the illness to his pediatrician and stated that it appeared he was having a reaction to the MMR vaccine. She was quickly dismissive of this idea and gave a long explanation about how teenagers notoriously ignore signs and symptoms of illness for so long that they develop a fever to finally force them to stop all activities and rest. She then stated that it sounded like he had the flu. I informed her that we had been through at least five flu illnesses with our son and he had never manifested any like this. I questioned the severely delayed fever and joint pain. Again, she tried to reassure by diagnosing this as the flu. Our sons continued to have a fever for  a total of 24 hours then regained his energy by day 15 post MMR vaccine.
"large bruise" at the vaccination site; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed a large bruise at the vaccination site and asked if that was normal. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a 69-year-old male who on 26-JUL-2006 was vaccinated with a dose of Varivax. It was reported that Zostavax was ordered but Varivax was given. Subsequently, the patient did not experience any adverse events. Additional information has been requested.
RECEIVED VACCINES ON 8/27/07. APPROXIMATELY 24 HOURS LATER DEVELOPED SOME SWELLING, REDNESS AND TENDERNESS IN THE LEFT UPPER ARM AT THE SITE OF THE DTAP.  WAS SEEN AT THE ER ON 8/29/07.  TREATED WITH CLINDAMYCIN AND KEFLEX FOR "CELLULITIS".  WAS SEEN BY DR ON 8/30/07 DIAGNOSED WITH REACTION TO DTAP VACCINE. LEFT UPPER ARM FOUND TO BE SLIGHTLY SWOLLEN AND NON-TENDER.  THE RESOLVING ERYTHEMATOUS AREA WAS APPROX. 30 x 20 CM WITH SLIGHT INDURATION.  THERE WERE NO DRAINING GLANDS.  WAS REASSURED AND ADVISED TO COMPLETE 5 DAYS OF THE ANTIBIOTIC AND TO FOLLOW-UP PRN.  VIS ON DTAP WAS GIVEN AGAIN.
Achiness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-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 PAIN (Achiness) and PYREXIA (Fever). At the time of the report, PAIN (Achiness) and PYREXIA (Fever) had resolved.            Concomitant medication include cholesterol medication and sinuses medication (allergies). No treatment medication reported.  For the first shot, patient did not had much going on.  For the second shot, patient experienced a little bit of a fever and achiness but it went away within 24 to 48 hours.   This case was linked to MOD-2021-377201 (Patient Link).
5cm circular area of erythema & swelling @ inject site (DTAP); 4 cm circular area of erythema & swelling @ lt thigh HIB inject site; discolored flat area w/irregular border on rt arm below deltoid (reddish brown discoloration noted) by mom;
Patient received vaccine around 6pm and had some swelling in her ankle around 9pm bilateral. States she thought the inside of her cheek was swollen but thinks it doesn't feel any different now than it did then and think she was just in her head about it. She forgot to take her BP meds that morning and took them the following day and swelling in her ankles went down within 24 hours.
After COVID patient continued to experience fatigue. We do NOT think this is a result of the vaccine.  The fatigue continued and in March 2021 we began more tests to determine the cause of the fatigue. She has slightly low Hemo numbers.  Eventually they found problem proteins in her blood that lead to a diagnosis of Waldenstrom's lymphoma.  We are getting a second opinion.  No one has suggested this is due to the vaccine.
Wrong vaccine administered; I lost all of my hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2023 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 23Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; levothyroxine sodium (SYNTHROID), since 23Oct2023 (Batch/Lot number: unknown). The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: DEAFNESS (medically significant) with onset Oct2023, outcome "unknown", described as "I lost all of my hearing"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 23Oct2023, outcome "unknown", described as "Wrong vaccine administered". Therapeutic measures were not taken as a result of deafness. Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested positive for COVID-19. Patient had no known allergies or reported other medical history. Patient received other medications within 2 weeks of vaccination.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
no adverse effects were provided; inadvertently administered one dose of expired PROQUAD; This spontaneous report was received from a medical assistant referring to a 4 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 23-OCT-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (lot # R011216, expiration date 15-OCT-2019, route and strength were not reported) for prophylaxis (expired product administered). No adverse effects were reported.
The patient received too many vaccines; This non-serious spontaneous safety report, with case number 02316824, was received by partner, on 12Jan2023 and forwarded on 12Jan2023 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Inappropriate schedule of product administration".  Further information is expected.  FOLLOW-UP information, with reference number 02316824 and reference number 2022SA508562, was received from the partner on 26-JAN-2023. The case is maintained as non-serious.   The partner confirmed that the initial receipt date was on 13-DEC-2023.  Due to the nature of the event, the causality between the event "The patient received too many vaccines" and Vaxelis was not applicable.  Further information is expected.  Non-significant follow-up information was received on 23-FEB-2023 from the consumer.  Due to the nature of the event, the causality between the event "The patient received too many vaccines" and Vaxelis was not applicable.  Further information is not expected.
flush, faintness, weakness, dizziness, large rash at injection site x 4 days
A report has been received from a Health Professional concerning a 9 month old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST was started on an unknown date. The patient experienced inadvertently gave FLUMIST to a 9 month old which started on 10-Oct-2012. Pediatric office inadvertently gave FLUMIST to a nine month old patient on 10-Oct-2012. Patient experienced no symptoms at the time of administration, and no symptoms were reported at the time of reporting either. The patient recovered from the event of inadvertently gave FLUMIST to a 9 month old on an unspecified date. The report was considered to be non-serious.
Severe shaking/shivering in the core body, some muscle cramping in arms and legs, red swelling at injection site. Patient reported feeling feverish, but when temperature was taken, there was no fever. Severe shivering lasted approximately 1 hour, then symptoms subsided except for the red swollen injection site, which lasted 3 days.
Patient reported red, swollen, warm bump on arm located 1 to 2 inches above inner elbow on left arm.
This spontaneous report was received from a registered nurse, referring to 34 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From On 04-MAY-2016 to 27-MAY-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L025738 with expiration date on 14-AUG-2017 and lot # L033343 with expiration date on 13-SEP-2017, (strength, dose, frequency, route and anatomical location were not reported). No adverse effect reported and no product quality complaint was involved. Temperature: Min 20.7 degrees F for 13 hours and 46 minutes Max 47.3 degrees F for 12 minutes. (Cumulatively over the course of 2 days 04-MAY-2016 and 05-MAY-2016). Previous excursion: No. Was data logger involved: Yes. Additional information has been requested.
Administered on 9/23/16 arm got itchy and redness with hives extended down her arm along w/swelling. Redness and swelling lasted 8 days. Itchy for only 2 days. No allergies.
Pink swelling in the injection site; Pink swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink swelling in the injection site) and VACCINATION SITE SWELLING (Pink swelling in the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE DISCOLOURATION (Pink swelling in the injection site) and VACCINATION SITE SWELLING (Pink swelling in the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink swelling in the injection site) and VACCINATION SITE SWELLING (Pink swelling in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
20FEB91 temp 103 MD gave mom order to omit Pertussis from further immun;
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patient of unknown age and gender. Approximately on an unknown date in 2012, the patients were vaccinated with a dose of GARDASIL (lot number 0420AE, other lot numbers were reported as H010436 and H010364, expiry date, dose and route were not reported) that had a temperature excursion of 26 Fahrenheit for 17.5 hours and unsupported. This was a cumulative time frame and may have been occurring since 26-NOV-2012. The patients would have been vaccinated with the unsupported GARDASIL as a result of temperature excursion. No concomitant medications were reported. This is one of the 2 reports received from the same reporter (MARRS- 1212USA007173). Additional information has been requested.
Pt was give a pfizer dose indicated for ages 12+.  Pt is feeling well, no reported adverse side effects at this time
Red inflamed injection site, cleared after 4 days. Total body itchiness, cleared after 4 days. Irregular racing heart beat, on going. Swollen lymph node in clavical region, on going.
Severe sharp pain and swelling right arm focussed on injection site for Tdap.  Pain into axilla, shooting down arm and into shoulder and neck.  No dyspnea, no difficulty swallowing or chewing.  12 cm induration with erythema, plus guarding and tenderness axillary nodes. Onset on or around 3-13-09.  Patient treated with Ultram, Benadryl, Medrol Dos Pack, ice and aleve.
body aches; This is a spontaneous report received from a Pfizer sponsored program. The contactable nurse reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced body aches on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a seven patients (unknown gender) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to over dose, inappropriate age at vaccine administration (seven patients who were under 65 years received FLUZONE HD vaccine) and Off label use (off label use of FLUZONE HD). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.