chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wrong needle size used; A spontaneous report was received from a pharmacist concerning 31-year-old, male patient who who received Moderna's COVID-19 vaccine (mRNA-1273) and the wrong needle size was used [Product administration error].   The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 13-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The pharmacist reported that the nurse made an administration error today by using the wrong size of needle.   Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event were resolved.; Reporter's Comments: This report refers to a case of a 31-year-old male patient who experienced non-serious event of the wrong needle size was used (Wrong technique in device usage process ) for administration of  mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of the wrong needle size was used.
My husband and I had went to the theater and I had also watched my grandson. I thought I had a sinus infection, they were congested and I was starting to feel unwell. I awoke the next day not feeling good and took a home COVID-19 test, and it came back negative. The next day I was feeling a bit worse, I was feeling achy and coughing, I took another test and this one came back positive. I waited a couple of hours and took a second home COVID-19 test and it also came back positive. I called my primary care physician. We had a telehealth visit, he prescribed the PAXLOVID, ibuprofen. I am now feeling much better, just a lingering cough.
Patient was still at the doctor's office when reaction occurred. Patient had similar reaction as his brother, passing out and then vomited. Patient felt better after getting sick. His reaction was not as long but happened quicker. Patient did not have to lay down. Mom put cold paper towels on his forehead.  Patient had ringing in his ears for about 5 minutes. Patient had pain at site of injection and upper part of arm at night and next day. Patient took no medicine and did not do any treatment at home. Patient left doctor's office after 1 hour and was fine.
Pt's mother called 12-21-11 relates pt had fever of 105.6 in his ear (pt had vaccines 12-20-11) during night, pt was given TYL & MOTRIN, fever did go down. Pt came into office on 12-21-11 saw CNP. Strep test neg, see office notes called mother 12-22-11; pt's mother related fever was 104 again during night. With MOTRIN fever is down pt acts ok. Eating & drinking ok - see next page and when MOTRIN wears off fever is back up again. On 12/23/11  dr prescribed amoxicillin 250/mg/5 ml for pt - 5ml po BID. Called mother on 12-27-11 so see how pt was doing - pt's mom related pt's fever back 12/24/11 and is doing fine now - pt's mother also related when fever broke. Pt broke out in a rash also.
Body ache; Headache; Llow grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Llow grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Llow grade fever). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Llow grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication and concomitant medication was reported.
arm soreness the day after the injection was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness the day after the injection was given".  Additional information: It was reported that patient received COVID vaccine for 5- to 11-year-old and experience above event. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild but constant pain in the opposite arm (right), MIld but constant pain in the area between neck and back. Pain lasted for about week and slowly went away.
Fever of up to 102; severe body aches; severe headache; injection site pain; tiredness; general fluish feeling; This is a spontaneous report from a contactable consumer.  A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 12:45 PM (Batch/Lot number was not reported) (age at the vaccination 51-year-old) as dose 2, single for covid-19 immunisation. The patient medical history included obesity on an unspecified date. The patient's historical vaccine included BNT162B2 as dose 1, Arm Left single for covid-19 immunization on 23Jan2021 at 12:30 PM (age at vaccination 51 years). Concomitant medications included omeprazole (OMEPRAZOLE), 5000 IU of vitamin D and multi vitamin taken for an unspecified indication, on an unspecified date. On 13Feb2021 05:00 am, the patient had experienced fever of up to 102, severe body aches, severe headache, injection site pain, tiredness and general fluish feeling. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included body temperature: up to 102 on 13Feb2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no Known allergies. The outcome of events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.  Follow-up (21May2021): Follow-up attempts completed. No further information expected.
No symptoms the day of vaccination but on 1/9 I woke with a headache and pain at the injection site. I had significant tiredness throughout the day. I also started to develop a painful area of redness distal to the injection site. On 1/10 I continued to have a headache and tiredness. The redness had increased on my left arm to ~6x3 inch area. By the afternoon I had a bumpy red itchy rash on several areas of both arms and my back and stomach. At that point I took Benadryl. The morning of 1/11 the rash had mostly resolved but I still experienced itchiness of the arms, stomach and back. I also had left armpit pain.
fatigue; extreme insomnia / Unable to sleep more than 30-45 minutes at a time; brain was on overdrive (anxiety thoughts that were somewhat irrational); brain was on overdrive (anxiety thoughts that were somewhat irrational); Sore arm; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 12:45 (Lot number: EP6955) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies like  Peanuts, tree nuts, soy" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOL; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (lot number: EN6203, time: 02:00 PM, Location: Left arm, Dose 1), administration date: 04Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "extreme insomnia / Unable to sleep more than 30-45 minutes at a time"; ANXIETY (non-serious), THINKING ABNORMAL (non-serious) all with onset 26Mar2021 01:00, outcome "recovering" and all described as "brain was on overdrive (anxiety thoughts that were somewhat irrational)"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "Sore arm"; FEELING ABNORMAL (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "brain fog"; FATIGUE (non-serious) with onset 27Mar2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, anxiety, thinking abnormal, pain in extremity, feeling abnormal, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported taking an unspecified multivitamin as concomitant medication. Events did not result to emergency room visit and physician office visit.  No follow-up attempts are possible. No further information is expected.
Mother of the baby reported that during the night after receiving the vaccines the baby started to complain and developed a fever. Next morning the baby had a skin rash in the head. Her pediatrician recommended to check the vaccine lot.
Information has been received from a consumer concerning her16 year old smoker female friend; who a few days ago was vaccinated with the first dose of GARDASIL (lot number and site of administration not reported). A few days ago, the consumer stated that her friend was "feeling sick", dizzy and was vomiting. The patient was sent home early from school as a result. The patient drank cold water as treatment for the adverse events. The patient did not seek medical attention. At the time of the report, the patient had not recovered. No further information is available.
No adverse event.  Vaccine expired on 11/11/2022 while vaccine was given on 11/14/2022.
The patient was admitted to the Medical Center from an outside emergency department. Notes stated that the patient tested covid positive at his PCP's office on 03-05-2023. I do not have this test.  He did test Covid positive on 03-07-2023.  He was converted to Palliative Care on 03-13-2023.  Nurse walked into the patients room on 03-14-2023 at 12:00am and found the patient had expired.
Pain in my arm at injection site; Small red round spot with itchiness at the injection site; Small red round spot with itchiness at the injection site; It (injection site) was warm to touch; A spontaneous report was received from a consumer concerning himself, of age 44 years old, female who received Moderna's COVID-19 vaccine and experienced the events of "small red round spot with itchiness at the injection site", "pain in my arm at injection site" and "it (injection site) was warm to touch".  There were no medical history and concomitant medications reported.  On 26-Dec-2020, patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly on the left arm for prophylaxis of COVID-19 infection.  On 27 Dec 2020, in the morning, the patient experienced pain in my arm at injection site, warm to touch, small red round spot at the injection site which has gotten bigger and itchiness at the injection site. No treatment was administered.  On 28 Dec 2020, the event, pain in my arm at injection site was resolved but, the red circle got bigger and it was still warm to touch. It is only slightly itchy. The patient did not take any treatment medications for the events.  Action taken with mRNA-1273 in response to the events were not reported.   The events small red round spot with itchiness at the injection site and It (injection site) was warm to touch were not resolved. The event pain in my arm at injection site was resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 44-year-old, female patient. The patient's medical history was not provided. The patient experienced non serious, expected event of injection site urticaria, erythema, pain,  and an unexpected event of injection site warmth. The event occurred 2 days after the first dose of mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 75 year old female patient. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000494, 0.65 ml, subcutaneous. On an unknown date in 2013 the patient experienced painful swelling about the size of a half dollar at the injection site. The patient sought medical attention by calling her pharmacist. The pharmacist reported that the patient has been putting ice on it, and he will go visit the patient at her home today. The outcome of painful swelling about the size of a half dollar at the injection site was reported as not recovered. The relatedness of the event was not reported for ZOSTAVAX. Additional information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 16-MAR-2015, the patient received an expired dose of ZOSTAVAX lot # k003596, expiry date 12-MAR-2015, 0.65 ml, subcutaneous. There were no adverse effects reported. It was unspecified if the patient sought medical attention. Additional information is not expected as the reporter declined to provide any patient specific information.
COVID-19; COVID-19; This is a spontaneous report from a non-contactable other hcp received (Reference: LRN4357235). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included RITUXAN taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced covid-19. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. Additional information including event onset date, concomitant medications and their indications, concurrent medical conditions, medical history, diagnostic test results, treatment done, is needed to better assess this report.
This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported). On an unknown date after receiving ZOSTAVAX, the patient experienced shingles. The outcome of the event shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
In addition to the 'normal' shot symptoms; red, swollen arm, hot to the touch...approximately 3 days after the shot, I began noticing bumps on my face. They continually go worse over the next few days, and became very painful blisters. I ended up in the emergency room on 10-16-21 simply because the pain was too much to bear.
After receiving ADACEL TDaP vaccine at my primary provider office I began to experience hearing loss about 3 days later. I also received FLUZONE-QUAD at the same visit. This hearing difficulty persists to this date.
2021:  On April 2 Mom received her first COVID-19 "vaccination" at local Community Health Center - Moderna 018B21A On April 30 Mom received her second COVID-19 "vaccination" at local Community Health Center - Moderna 009C21A  Some time near the end of May, she fell in her house and broke her hip. Her hip was repaired at regional Hospital.  From there she went to local Rehab center for a few weeks. At Rehab Center, she had an elevated white blood count and was diagnosed with and treated for a urinary tract infection.   When rehab was complete, she lived at local Assisted Living facility for a month (June 21 - July 20), and then came to live with us in our home starting on July 21.  During this time, we noticed that she had a persistent cough. The cough continued until her death in 2022.  2022:  Around the beginning of July, Mom broke out in tiny red dots all over her arms and neck. She thought they were mosquito bites, but in hindsight, they may have been a symptom of the leukemia that was yet to be diagnosed a month later.  Friday evening, August 12, we took Mom to local Hospital because she had been vomiting all day. She was not able to keep anything down, including liquids.  She had been nauseous over the prior 2 - 3 weeks, complaining that we gave her too much food, or too much bread for her lunch sandwiches. She felt full after eating just a few bites. She stopped eating her sweet treats.  (As an aside, she had a primary care well visit on Tuesday, August 2 with her Dr. at the Primary Care center. She did not tell the doctor about these symptoms.)  At Hospital emergency room, on August 12, they put her on fluids and took some blood. Her white blood cell count was off the chart, so they did a second test. It was still off the chart (186). The doctors at hospital immediately diagnosed leukemia and arranged for transport to alternate local Hospital that same evening and she was admitted there.  At alternate Hospital, she was treated by MD, Hematologist-Oncologist.  She was diagnosed with Acute Myeloid Leukemia, undetermined sub-type (did not match anything known).  She was treated with chemotherapy and immunotherapy with no improvement, and was very ill.  On Saturday, August 20, she made the decision to stop treatments and proceed with hospice care.  On Tuesday, August 22, she was transported to the local Hospice Care facility.  On Wednesday, October 5, she died there at 14:10.
small nodule to injection site; Itching worsened; Itching in the arm  of injection; Redness in the arm of injection; Sore in the arm of injection; swelling in the arm of injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection) and VACCINATION SITE PAIN (Sore in the arm of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 307K20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 29-Dec-2020 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021 at 12:24 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection). The patient was treated with IBUPROFEN (oral) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of 1 dosage form. On 12-Jan-2021, VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection) to be possibly related.    It was noted per follow-up report that the patient had a delayed topical reaction to the TB skin test.   This case was linked to MOD-2021-031261, MOD-2021-027551, MOD-2021-025815, MOD-2021-028822, MOD-2021-028858 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow-up ADR form received and contained first and second dose details, concomitant/treatment medications, event onset and resolution dates, medical history and causality.
I had a case of Covid in the summer of 2020 which resulted in admission to a hospital, so I expected a strong reaction to the vaccine. I had chills, body aches, fatigue and elevated responses that one would expect from the vaccine; however, I also experienced extreme shortness of breath with pulse oxygen levels dropping consistently in the days following the injection. The lowest that it measured was about 74% and the lowest it measured that I was able to document was 79%. It was almost like having covid again. I ended up in the ER, where blood tests revealed elevated D-dimers which resulted in  a chest x-ray followed by a chest CT was  to rule out any embolism. The rest of the week was miserable. I also missed work. Clearly, I already have a strong response to covid and don't think taking the second shot will result in a benefit that outweighs the risk, so I do not want to have to get the second shot. How can I seek an exemption from a second shot? Can I be considered fully vaccinated with one shot since I also had Covid and studies indicate people who had double Covid pneumonia have extremely low rates of reinfection. If I have to get a second shot who will cover my medical bills and missed work?
A 17 year old male was given 0.25ml Moderna booster as their third dose. Patient had originally gotten Pfizer as first and second dose as they are not eligible for Moderna given their age.  No known adverse event aside from being given the incorrect booster based on patients age.
Patient was on her knees accessing a drawer last night and then she acutely could not get up and felt profound weakness to her feet and legs. She had to "scooch" herself across the room which took a couple of hours. She denied any loss of bladder or bowel control. She basically lost her motor strength to her legs but she reports she could feel sensation to her legs. She denied any vision or swallowing problems.
Patient not in distress, no swelling and redness. No adverse effect as noted after under 5 y/o (0.25 ml/IM) Moderna covid vaccine administered. Per patient's father, the patient got the first dose on the thigh and would like to get the second dose on the thigh again. This nurse administered (0.25ml/IM) under 5 moderna covid vaccine on the thigh using a 5/8" needle. This nurse was flagged by RN supervisor on site.