chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED LESS THAN 0.5ML OF  VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 70 year old white male of an unspecified ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s  (manufacturer not specified) (suspension for injection, route of admin not reported, batch number and expiry were unknown), 1 in total, dose was not reported, for prophylactic vaccination (dose number in series 1). No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) dose was not reported, 1 total administered on 01-DEC-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported. On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster dose, the patient experienced received less than 0.5 ml of the vaccine as a booster dose and off label use (dose number in series 2).   As per the report, "the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL"  (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210733, 20211210588, 20211210112, 20211210610, 20211210159, 20211210409, 20211210555, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211209775, 20211210334, 20211210385, 20211210590, 20211210350, 20211210180, 20211210165, 20211210143, 20211210585, 20211210058, 20211210549, 20211210684, 20211209798, 20211210670, 20211210824, 20211210107, 20211209679, 20211209706, 20211209740, 20211210019, 20211210106, 20211210141, 20211209740, 20211209679, 20211210133 and 20211210141.
Patient received 2 doses at the same day (dose #2 and #3 by mistake). No reaction.
Fever, sneezing, arm pain, swollen in injection area, itching,  and low energy (really tired)
02/10/2022 Started with Diarrhea and it lasted for longer than expected for what I initially blamed it on lasts nights dinner. As it stands, I put myself on a soft diet and starting on (2/15) take two of major loperamide hydrochloride tablets for each BM after trying a solid meal. 02/18 Went to my PCP office where they blood test and was advised to call my GI doc if it last for more than a week.
vial with lot(066F21A) which was expired on 3-Apr-2022 was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial with lot(066F21A) which was expired on 3-Apr-2022 was administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial with lot(066F21A) which was expired on 3-Apr-2022 was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial with lot(066F21A) which was expired on 3-Apr-2022 was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. No side effects were reported after vaccination.
The R.N. received a flu vaccine prior to going home after night tern.  After she woke up, late afternoon, she noticed a generalized rash and itching hives.  She took a Benadryl capsule.  No fever was noted or any other symptoms.  Within a few hours, the symptoms were resolved. Symptoms resolved within 24 hrs. Rash and hives were initially noted to left arm then  later to front of the legs and stomach very sparsely.
Severe pain with movement of arm, significant swelling "as big as a softball", redness, fever, and vomiting.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L030158 expiration date 11-AUG-2016. The patients' concomitant medications were not reported. The pharmacist stated that VARIVAX (Merck) was exposed to a temperature excursion of -4 degrees C for 1 hour time frame. There was not previous temperature excursion reported. At the time of the report, no adverse effects were reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter. (1603USA010554).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 at 17:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Jan2021 at 15:45 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Aug2021 at 03:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Feb2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills/fever/spinning/dizzy/dropped at work so left and went to urgent care where they did a rapid covid test which was neg/ said to go to the ER/ I waited until next day when I seem to get worse ans ended up in the Emergency room having a hard time breathing/vomiting/dizzy/and couldnt even walk/after several test and keeping me overnight, i was diagnosed with vertigo and came home the tinnitus began and i still have i was sent home on meclizine and zofran.
The same night I received the booster I developed a severe headache (same as with previous second dose) and took Tylenol. I woke up in the middle of the night (maybe 3 or 4 am) with severe vertigo, headache and ringing in my ears. The vertigo symptoms became less severe on March 5th that I could at least drive again. I still have positional episodes. The ringing in my b/l ears has not lessened. I have a continuous low volume ringing with period of loud ringing in one or both ears (varies). My headaches are better than at onset but continue.
Mother report only!  Mother reports child needing hospitalization for seizures and has suffered weakness and significant fatigue since H1N1 vaccination.
Pt. was given Flu vaccine 1/14/2011 at 9 AM. Pt reports later that same day at approx. 9 pm began having chills, aches, congestion. Continued to feel "bad" all weekend. Began with a fever Sunday 1/16/2011. 102.5 was the highest she sts her fever got to.
Muscle and joint pain, loosing balance because of joint pain, headache, vertigo, loosing balance because of vertigo, lose of appetite
Constant headache since first dose about an hour later. Varies in level of intensity, but still have it a week later.  Also developed pain, itching and swelling  on right arm today starting when I woke up. It is about a 3 inch radius from center of injection site and it hurts to use my arm.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 3:39 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 31-Jan-2022 at 3:39 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient ethnicity was reported.  On 31-Jan-2022 at 15:39:19, Patient administered second dose.   It was reported that patient received lot its 30 day expiry date.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
I took the Moderna Covid vaccine on 12-28-2020 at 1420. After getting the shot, I had a metallic taste in my mouth and drank some water then waited 20 mins. When I left to go back to my department, I started getting dizzy and coughing. I sat down in my department and could not stop coughing so I went to the ER department. My eyes were swollen, I had a rash from my arms and legs all the way down my body. I had hives on my face and my eyes were swollen. I was coughing and wheezing. the ER RN started an IV and I was given steroids, diphenhydramine, ondansetron and IV fluids. I was also given some cough medicine. I was monitored for a few hours and before I left - they gave me hydroxyzine for the hives and itching. The PA also ordered meds for me to take at home.      - per patient report
Beginning 01/03/2021 irritation in lymph nodes in right arm. Beginning 01/04/2021, additional irritation in lymph nodes in right side of neck.
Information has been received from a registered nurse concerning a 22 week old female patient who on 06-JAN-2009 was orally vaccinated with the third dose of ROTATEQ (lot # 660881/0310X). It was reported that on 06-JAN-2009 the patient developed diarrhea, persistent vomiting, fever and oliguria since receiving her third dose of ROTATEQ. The patient was seen in the local emergency room and was prescribed unspecified anti-diarrhea medication. The patient was then examined in the office on an unspecified date and was prescribed PEDIALYTE. The parents of the patient called the physician's office today to relay that the symptoms have not improved and were referred to the local pediatric urgent care facility. The nurse considered the patient's diarrhea and persisting vomiting, fever and oliguria to be disabling and immediately life-threatening. A lot check has been requested. Additional information has been requested.
I was awakend at 12:45 am to a full body rush which sat me up in my bed. Full awake, my heart started to beating wildly/racing/heart palpitations. My muscles were all twitching and I had a buzzing all over. I didn't know what was happening I thought I may be having a heart attack or a stroke.I thought very seriously about going to the emergency room but knew that I couldn't drive. I also knew it would be ridiculously expensive to call 911. Thinking it was something I ate I tried to induce vomiting. I was unsucessful and just tried to lay back down and hoped it would pass. Since it had been 3 days since I got my shot it didn't dawn on me that it could be the shot until the next day when I got up to find I had acont
C/o numbness at injection site, right deltoid, including arm and fingers. Equal strength noted in both arms and hands. Mother was called who stated that daughter "does this with shots". Sent to school nurses's office for observation. 12:45 Student denies any numbness. Equal strength present in both arms.
Information has been received from a physician concerning a 10 yr old male who on 25Sep95 was vaccinated with a dose of varicella virus vaccine live (lot608667/0426B). On approx 09May05, the pt developed breakthrough, described as 50 lesions with no fever. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 12-AUG-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscular which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine.   Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient developed a red, warm, and itchy left upper extremity, from shoulder to elbow about a week after her injection. Has been waxing and waning for the past week. No further systemic symptoms.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Vaccine was expired on Aug 18,2022 and Vaccine was given 09/08/2022. Went to go document vaccine given in system and it wouldn't show lot number.  Recognized it was expired. Called and told patients mother to let her know what happened and that she needs to return for a revaccination.
This spontaneous report was received from a physician and refers to a non-pregnant female patient of unknown age. The patient did not have any concomitant medications, pertinent medical history, drug reactions or allergies. On 15-DEC-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiry date were not provided) for prevention of shingles. On 15-DEC-2017 (reported as "later in the day, after receiving the injection"), the patient experienced body aches, hard time swallowing, chest feeling heavy, and taste buds changing. No lab diagnostic was performed. On 18-DEC-2017, the patient came to the physician's office. No specific treatment was given, as the patient stated feeling better by the time they saw the physician. The outcome of the events was reported as recovering. The causality assessment was not provided.
4/8/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  Feeling light headed and weak.   Assessment : Time of assessment 0947, patient sloughing in chair feeling faint. Able to answer questions.   Actions taken: Taken to stretcher, Vitals sign taken  VAERS form obtained and completed by RN.  0947- 142/78, P- 88, RR- 16. O2- 100% 0957- BP127/66. P- 84,  - 0952- CBG- 84 Water given.       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Mom with patient.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/8/2021  9:42 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8729
The pt experienced chest tightness and shortness of breath. Use Albuterol inhaler 2 times for relief. Shortness of breath and chest tightness continued for awhile but did not seek physicians treatment. Ok the following day.
Pt. endorses pain, swelling, decreased ROM of left shoulder; diminished sensation of inferolateral left forearm, left palm, left 4th/5th digit.
Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of PROQUAD SQ at 12 months of age. Subsequently, the patient experienced "a full blown case of the chicken pox at 21 months of age". The outcome was not reported. The patient sought unspecified medical attention. The physician is planning on giving the patient the second dose of PROQUAD. Additional information has been requested.
Information has been received from a health professional concerning a 66 year old male with a history of chronic shoulder pain, a history of chest pain, shoulder bursitis, and who was seen in the past by a neurologist for his left shoulder pain who on 7/22/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 7/24/03 the pt could not move his arm, with no swelling or tenderness. On 8/15/03 the pt developed a sore throat, congestion, shortness of breath and pain in left shoulder with tenderness in the shoulder, with full range of motion, a slight tenderness at injection site, and was diagnosed with right deltoid bursitis. The pt was given cortisone injection in the bursa and rofecoxib, 50mg daily for 4 days and then 25mg daily. It was also noted that he was treated with anti-inflammatories in the past. The doctor wanted to determine if the lot that was given to the pt had any similar problems. Although the physician vaccinated the pt, he did not record the lot number in the chart, so the reporter was unable to provide this information. It was also noted that the physician felt that the bursitis was not related to the pneumococcal 23v polysaccharide vaccine, but he was trying to determine whether the vaccine aggravated the pt's condition. Upon internal review, the pt's conditions of "he could not move his arm," pain in the left shoulder of increased intensity, and right deltoid bursitis, were considered important medical events (OMIC). Additional info has been requested. Follow up on 10/28/2003: "This is an amended report.  The adverse event section now reads "injection site tenderness" instead of "injection site discomfort".  This is a corrected report as amended."